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出境医 / 临床实验 / Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention (PHOEBI)

Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention (PHOEBI)

Study Description
Brief Summary:

Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss.

Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation.

Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.


Condition or disease Intervention/treatment
Obesity Hypoventilation Syndrome (OHS) Procedure: Bariatric Surgery

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention: PHOEBI Study
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
Group/Cohort Intervention/treatment
Hypercapnic
Obese patients with daytime hypercapnia
Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery

Eucapnic
Obese patients with normal daytime carbon dioxide levels
Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery

Outcome Measures
Primary Outcome Measures :
  1. Expiratory flow limitation as measured by forced oscillation testing [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patients has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of expiratory flow limitation at different position including upright, 45 degrees and supine. We will explore whether expiratory flow limitation can differentiate hypercapnic and eucapnic patients

  2. Degree of change in expiratory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Explore whether the degree of positional change in expiratory flow limitation can differentiate between eucapnic and hypercapnic patients


Secondary Outcome Measures :
  1. Closing capacity [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of closing capacity at different position including upright, 45 degrees and supine. We will explore whether expiratory flow limitation can differentiate hypercapnic and eucapnic patients

  2. Degree of change in closing capacity [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Explore whether the degree of positional change in closing capacity can differentiate between eucapnic and hypercapnic patients

  3. Correlation between closing capacity and expiratory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Compare outcome 1 and 3 to explore whether there is a relationship between expiratory flow limitation and closing capacity

  4. Intra-abdominal pressure [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will measure intra-abdominal pressure and explore whether hypercapnic patients have increased intra-abdominal pressure. Positional changes will be measured

  5. Correlation between intra-abdominal pressure, closing capacity and expriatory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Compare outcome 1,3 and 6. This is a complex multi-compartment model that can differentiate hypercapnia and eucapnic patients

  6. Upper airway collapsibility [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of upper airway collapsibility as measure by negative expiratory pressure. Explore whether there is a relationship between hypercapnic and eucapnic patients depending on degree of upper airway collapsibility

  7. Lung compliance [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of lung compliance with pressure volume curve including measurements in different positions (upright, 45 degrees and supine)

  8. Respiratory muscle strength (maximal inspiratory pressure/maximal expiratory) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of inspiratory and expiratory muscle strength

  9. Respiratory muscle strength (SNIP test) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of sniff nasal inspiratory pressure

  10. Daytime neural respiratory drive (para-sternal electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Daytime neural respiratory drive as measured by parasternal electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients

  11. Daytime neural respiratory drive (diaphragm electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Daytime neural respiratory drive as measured by diaphragm electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients

  12. Nocturnal neural respiratory drive (para-sternal electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Nocturnal neural respiratory drive as measured by parasternal electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients

  13. Nocturnal neural respiratory drive (diaphragm electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Nocturnal neural respiratory drive as measured by diaphragm electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients

  14. Quality of life post bariatric surgery with SF-36 [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Quality of life changes after bariatric surgery more than with standard medical therapy

  15. Quality of life post bariatric surgery with EQ-5D [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Quality of life changes after bariatric surgery more than with standard medical therapy

  16. Symptom change after commencement of medical therapy compared to bariatric surgery measured with Epworth Sleepiness Scale [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy

  17. Symptom change after commencement of medical therapy compared to bariatric surgery measured with mMRC (modified medical research council) dypnoea score [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy

  18. Symptom change after commencement of medical therapy compared to bariatric surgery measured with Multi-dimensional dyspnoea profile [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy

  19. Symptom change after commencement of medical therapy compared to bariatric surgery measured with Severe Respiratory Insufficiency Questionnaire [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy

  20. Changes in healthcare resource usage in OHS patients post bariatric surgery [ Time Frame: 6 months pre bariatric surgery and 6 months post bariatric surgery ]
    Estimation of healthcare usage cost in the 6 months prior to surgery and 6 months post surgery including medication costs and re-admissions to hospital

  21. Improvement in daytime CO2 levels [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Arterial blood gas performed before and after bariatric surgery with improvement in CO2 levels

  22. Improvement in apnoea-hyponoea index [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery

  23. Improvement in mean nocturnal oxygen saturation during sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery

  24. Improvement in mean time spent below 90% oxygen saturation during sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery

  25. Changes in sleep architecture measured by %slow wave sleep and %REM sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery

  26. Improvement in diaphragm function [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Diaphragm thickening will be measured by ultrasound assessment

  27. Improvement in glycaemic control [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    HbA1C will be measured before and after bariatric surgery


Other Outcome Measures:
  1. Spectrum of sleep disordered breathing [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will look at sub-group analyses for outcomes 1-29 based on degree of hypoventilation as defined by ERS/ESRS working group

  2. Choice of bariatric surgery [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will investigate whether outcomes 1-29 is different depending on type of surgery the patient undergoes (gastric bypass compared to gastric sleeve)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese patients who are considering bariatric surgery intervention
Criteria

Inclusion Criteria:

  1. Patients 18 years or older
  2. BMI > 40
  3. Patients with significant sleep disordered breathing requiring treatment
  4. Patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery

Exclusion Criteria:

  1. Patients with decompensated hypercapnic respiratory failure (pH< 7.3)
  2. Chronic hypercapnic respiratory failure due to a cause other than obesity such as neuromuscular, chest wall or airway disease
  3. Unstable cardiac disease including coronary artery disease and heart failure
  4. Significant co-morbid psychiatric disease requiring anti-psychotic medications
  5. Chronic pain syndrome on high dose opioid medications
  6. Treatment for drug or alcohol addiction
  7. Cognitive impairment that would prevent informed consent
  8. Pregnancy
  9. Need for long-term renal replacement therapy
  10. Patients who undergo bariatric intervention with gastric balloon or gastric band.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Michael Cheng, MBBS +44 02071888070 michael.cheng@gstt.nhs.uk

Locations
Layout table for location information
United Kingdom
Guy's and St Thomas' NHS Trust Recruiting
London, United Kingdom, SE17EH
Contact: Michael Cheng, MBBS    +44 02071888070    michael.cheng@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Joerg Steier, PhD Guy's and St Thomas NHS Trust
Tracking Information
First Submitted Date June 21, 2019
First Posted Date July 19, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date June 20, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Expiratory flow limitation as measured by forced oscillation testing [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patients has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of expiratory flow limitation at different position including upright, 45 degrees and supine. We will explore whether expiratory flow limitation can differentiate hypercapnic and eucapnic patients
  • Degree of change in expiratory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Explore whether the degree of positional change in expiratory flow limitation can differentiate between eucapnic and hypercapnic patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Closing capacity [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of closing capacity at different position including upright, 45 degrees and supine. We will explore whether expiratory flow limitation can differentiate hypercapnic and eucapnic patients
  • Degree of change in closing capacity [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Explore whether the degree of positional change in closing capacity can differentiate between eucapnic and hypercapnic patients
  • Correlation between closing capacity and expiratory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Compare outcome 1 and 3 to explore whether there is a relationship between expiratory flow limitation and closing capacity
  • Intra-abdominal pressure [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will measure intra-abdominal pressure and explore whether hypercapnic patients have increased intra-abdominal pressure. Positional changes will be measured
  • Correlation between intra-abdominal pressure, closing capacity and expriatory flow limitation [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Compare outcome 1,3 and 6. This is a complex multi-compartment model that can differentiate hypercapnia and eucapnic patients
  • Upper airway collapsibility [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of upper airway collapsibility as measure by negative expiratory pressure. Explore whether there is a relationship between hypercapnic and eucapnic patients depending on degree of upper airway collapsibility
  • Lung compliance [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of lung compliance with pressure volume curve including measurements in different positions (upright, 45 degrees and supine)
  • Respiratory muscle strength (maximal inspiratory pressure/maximal expiratory) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of inspiratory and expiratory muscle strength
  • Respiratory muscle strength (SNIP test) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Measurement of sniff nasal inspiratory pressure
  • Daytime neural respiratory drive (para-sternal electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Daytime neural respiratory drive as measured by parasternal electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients
  • Daytime neural respiratory drive (diaphragm electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Daytime neural respiratory drive as measured by diaphragm electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients
  • Nocturnal neural respiratory drive (para-sternal electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Nocturnal neural respiratory drive as measured by parasternal electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients
  • Nocturnal neural respiratory drive (diaphragm electromyography measurements) [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Nocturnal neural respiratory drive as measured by diaphragm electromyography (EMG) measurements can differentiate between hypercapnic and eucapnic patients
  • Quality of life post bariatric surgery with SF-36 [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Quality of life changes after bariatric surgery more than with standard medical therapy
  • Quality of life post bariatric surgery with EQ-5D [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Quality of life changes after bariatric surgery more than with standard medical therapy
  • Symptom change after commencement of medical therapy compared to bariatric surgery measured with Epworth Sleepiness Scale [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy
  • Symptom change after commencement of medical therapy compared to bariatric surgery measured with mMRC (modified medical research council) dypnoea score [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy
  • Symptom change after commencement of medical therapy compared to bariatric surgery measured with Multi-dimensional dyspnoea profile [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy
  • Symptom change after commencement of medical therapy compared to bariatric surgery measured with Severe Respiratory Insufficiency Questionnaire [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Symptom change after bariatric surgery is more than with standard medical therapy
  • Changes in healthcare resource usage in OHS patients post bariatric surgery [ Time Frame: 6 months pre bariatric surgery and 6 months post bariatric surgery ]
    Estimation of healthcare usage cost in the 6 months prior to surgery and 6 months post surgery including medication costs and re-admissions to hospital
  • Improvement in daytime CO2 levels [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Arterial blood gas performed before and after bariatric surgery with improvement in CO2 levels
  • Improvement in apnoea-hyponoea index [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery
  • Improvement in mean nocturnal oxygen saturation during sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery
  • Improvement in mean time spent below 90% oxygen saturation during sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery
  • Changes in sleep architecture measured by %slow wave sleep and %REM sleep [ Time Frame: Before bariatric surgery on enrolment and 6 months after bariatric surgery ]
    Patients will have diagnostic sleep study before and after bariatric surgery
  • Improvement in diaphragm function [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    Diaphragm thickening will be measured by ultrasound assessment
  • Improvement in glycaemic control [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    HbA1C will be measured before and after bariatric surgery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2019)
  • Spectrum of sleep disordered breathing [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will look at sub-group analyses for outcomes 1-29 based on degree of hypoventilation as defined by ERS/ESRS working group
  • Choice of bariatric surgery [ Time Frame: Measurements on enrolment into study; measurements prior to bariatric surgery (once patient has a surgery date); measurements 2-4 weeks after bariatric surgery; and end of study measurements 6 months after bariatric surgery ]
    We will investigate whether outcomes 1-29 is different depending on type of surgery the patient undergoes (gastric bypass compared to gastric sleeve)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention
Official Title Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention: PHOEBI Study
Brief Summary

Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss.

Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation.

Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Obese patients who are considering bariatric surgery intervention
Condition Obesity Hypoventilation Syndrome (OHS)
Intervention Procedure: Bariatric Surgery
Weight loss surgery with either gastric sleeve or gastric bypass surgery
Study Groups/Cohorts
  • Hypercapnic
    Obese patients with daytime hypercapnia
    Intervention: Procedure: Bariatric Surgery
  • Eucapnic
    Obese patients with normal daytime carbon dioxide levels
    Intervention: Procedure: Bariatric Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients 18 years or older
  2. BMI > 40
  3. Patients with significant sleep disordered breathing requiring treatment
  4. Patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery

Exclusion Criteria:

  1. Patients with decompensated hypercapnic respiratory failure (pH< 7.3)
  2. Chronic hypercapnic respiratory failure due to a cause other than obesity such as neuromuscular, chest wall or airway disease
  3. Unstable cardiac disease including coronary artery disease and heart failure
  4. Significant co-morbid psychiatric disease requiring anti-psychotic medications
  5. Chronic pain syndrome on high dose opioid medications
  6. Treatment for drug or alcohol addiction
  7. Cognitive impairment that would prevent informed consent
  8. Pregnancy
  9. Need for long-term renal replacement therapy
  10. Patients who undergo bariatric intervention with gastric balloon or gastric band.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Michael Cheng, MBBS +44 02071888070 michael.cheng@gstt.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04025528
Other Study ID Numbers 258045
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Joerg Steier, PhD Guy's and St Thomas NHS Trust
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date July 2019