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出境医 / 临床实验 / Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry

Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry

Study Description
Brief Summary:
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).

Condition or disease
Obstructive Sleep Apnea

Detailed Description:
During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months [ Time Frame: 3 months ]
    Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up


Secondary Outcome Measures :
  1. Changes in sleep-related quality of life from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in sleep-related quality of life assessed with the questionnaire FOSQ (Functional Outcomes of Sleep Questionnaire). The Functional Outcomes of Sleep questionnaire is a "self-report measure designed to assess the impact of disorders of excessive sleepiness on multiple activities of daily living" (Weaver 1997). It consists of 10 questions categorized as General Productivity, Social Outcome, Activity Level, Vigilance, Sexual Activity. The range of scores for any item is 1-4. The potential range of scores for the total score is 5-20, with 5 meaning bad sleep-related quality of life and 20 good sleep-related quality of life. The total score is being calculated by calculating the mean of the subscale scores and then multiply that mean by five. Missing or not applicable answers will not be added when calculating the mean subscale scores.

  2. Changes in daytime sleepiness from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in daytime sleepiness assessed with the Epworth Sleepiness Scale questionnaire (ESS, measures the likelihood of a patient of falling asleep during daytime as self-reported outcome). The ESS is self-reported measure to assess whether a person would be prone to fall asleep in typical daily situations. It consists of 8 questions that can be answered with 0 = would never fall asleep, 1 = slight probability of falling asleep, 2 = moderate probability of falling asleep, 3 = high probability of falling asleep. The scores will be added up to give a total ranging from 0 - 24 and indicating different levels of excessive daytime sleepiness (6-10 higher than normal; 11-12 mild; 13-15 moderate; 16-24 severe).

  3. Changes in snoring from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient's measure). The Thornton Snoring Scale consists of 5 questions that can be answered with 0 = never, 1 = infrequently, 2 = frequently, 3 = most of the time. The scores will be added and when the sum of all answers is higher than 5, a snoring problem is indicated.

  4. Usage of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked about how long and on how many days they were using the Narval MAD during the follow-up period. Patients will be offered a choice between "usage in total" - every night, 3-4 times a week, 1-2 times a week. Usage per night: Less than 1 hour, 1-3 hours, 4-5 hours.

  5. Side effects with use of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked if they experienced side effects and which kind of side effects: Temporomandibular joint pain, dental pain, hypersalivation, dry mouth, local irritation, inflammation, dental fracture, broken MAD/device defect.

  6. Document comorbidities of enrolled patients [ Time Frame: 3 months ]
    Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)

  7. Remuneration of a Narval MAD [ Time Frame: 3 months ]
    Patients will be asked whether they bought the Narval MAD themselves or if a public or private healthcare insurance provider paid the expenses

  8. Satisfaction with therapy [ Time Frame: 3 months ]
    Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).

  9. Document sleep disorders of enrolled patients [ Time Frame: 3 months ]
    Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)

  10. Continuation of therapy [ Time Frame: 3 months ]
    Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.
Criteria

Inclusion Criteria:

  • Prescription of a Narval CC mandibular advancement device
  • Age ≥ 18 years
  • Ability to understand the study information and information on usage of personal data
  • Signed and dated informed consent

Exclusion Criteria:

  • Patients with central sleep apnea (central AI > 5/hour)
  • Patients with loose teeth and severe parodontitis
  • Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Oliver Munt, PhD +491629056360 oliver.munt@resmed.de

Locations
Layout table for location information
Germany
Ruhrlandklinik Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45239
Contact: Christoph Schoebel, Prof    +49200143301    christoph.schoebel@rlk.uk-essen.de   
Contact: Sarah Terjung, MSc    +49200143301    sarah.terjung@rlk.uk-essen.de   
Sponsors and Collaborators
ResMed
Investigators
Layout table for investigator information
Principal Investigator: Christoph Schoebel, Prof Ruhrlandklinik Essen
Tracking Information
First Submitted Date March 26, 2019
First Posted Date April 23, 2019
Last Update Posted Date June 2, 2020
Actual Study Start Date May 27, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2019) 		Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months [ Time Frame: 3 months ]
Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2020)
  • Changes in sleep-related quality of life from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in sleep-related quality of life assessed with the questionnaire FOSQ (Functional Outcomes of Sleep Questionnaire). The Functional Outcomes of Sleep questionnaire is a "self-report measure designed to assess the impact of disorders of excessive sleepiness on multiple activities of daily living" (Weaver 1997). It consists of 10 questions categorized as General Productivity, Social Outcome, Activity Level, Vigilance, Sexual Activity. The range of scores for any item is 1-4. The potential range of scores for the total score is 5-20, with 5 meaning bad sleep-related quality of life and 20 good sleep-related quality of life. The total score is being calculated by calculating the mean of the subscale scores and then multiply that mean by five. Missing or not applicable answers will not be added when calculating the mean subscale scores.
  • Changes in daytime sleepiness from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in daytime sleepiness assessed with the Epworth Sleepiness Scale questionnaire (ESS, measures the likelihood of a patient of falling asleep during daytime as self-reported outcome). The ESS is self-reported measure to assess whether a person would be prone to fall asleep in typical daily situations. It consists of 8 questions that can be answered with 0 = would never fall asleep, 1 = slight probability of falling asleep, 2 = moderate probability of falling asleep, 3 = high probability of falling asleep. The scores will be added up to give a total ranging from 0 - 24 and indicating different levels of excessive daytime sleepiness (6-10 higher than normal; 11-12 mild; 13-15 moderate; 16-24 severe).
  • Changes in snoring from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient's measure). The Thornton Snoring Scale consists of 5 questions that can be answered with 0 = never, 1 = infrequently, 2 = frequently, 3 = most of the time. The scores will be added and when the sum of all answers is higher than 5, a snoring problem is indicated.
  • Usage of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked about how long and on how many days they were using the Narval MAD during the follow-up period. Patients will be offered a choice between "usage in total" - every night, 3-4 times a week, 1-2 times a week. Usage per night: Less than 1 hour, 1-3 hours, 4-5 hours.
  • Side effects with use of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked if they experienced side effects and which kind of side effects: Temporomandibular joint pain, dental pain, hypersalivation, dry mouth, local irritation, inflammation, dental fracture, broken MAD/device defect.
  • Document comorbidities of enrolled patients [ Time Frame: 3 months ]
    Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)
  • Remuneration of a Narval MAD [ Time Frame: 3 months ]
    Patients will be asked whether they bought the Narval MAD themselves or if a public or private healthcare insurance provider paid the expenses
  • Satisfaction with therapy [ Time Frame: 3 months ]
    Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).
  • Document sleep disorders of enrolled patients [ Time Frame: 3 months ]
    Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)
  • Continuation of therapy [ Time Frame: 3 months ]
    Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded
Original Secondary Outcome Measures
 (submitted: April 18, 2019)
  • Changes in quality of life from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in quality of life assessed with the questionnaire EQ-5D (EuroQoL 5-D measures the health status of a patient as self-reported outcome)
  • Changes in daytime sleepiness from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in daytime sleepiness assessed with the Epworth Sleepiness Scale questionnaire (ESS, measures the likelihood of a patient of falling asleep during daytime as self-reported outcome)
  • Changes in snoring from baseline compared to 3 months follow-up [ Time Frame: 3 months ]
    Changes in snoring assessed with a snoring questionnaire (the Thornton Snoring Scale contains 5 questions about snoring as subjective patient's measure)
  • Usage of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked about how long and on how many days they were using the Narval MAD during the follow-up period. Patients will be offered a choice between "usage in total" - every night, 3-4 times a week, 1-2 times a week. Usage per night: Less than 1 hour, 1-3 hours, 4-5 hours.
  • Side effects with use of the Narval MAD (mandibular advancement device) [ Time Frame: 3 months ]
    Patients will be asked if they experienced side effects and which kind of side effects: Temporomandibular joint pain, dental pain, hypersalivation, dry mouth, local irritation, inflammation, dental fracture, broken MAD/device defect.
  • Document comorbidities of enrolled patients [ Time Frame: 3 months ]
    Patients will be asked for relevant comorbidities (diabetes, hypertension, heart failure)
  • Remuneration of a Narval MAD [ Time Frame: 3 months ]
    Patients will be asked whether they bought the Narval MAD themselves or if a public or private healthcare insurance provider paid the expenses
  • Satisfaction with therapy [ Time Frame: 3 months ]
    Patients will be asked to rate their satisfaction with therapy on a scale of 1 (bad) to 10 (very good).
  • Document sleep disorders of enrolled patients [ Time Frame: 3 months ]
    Sleep disorders will be recorded with a polygraphy or polysomnography (obstructive sleep apnoea, central sleep apnoea)
  • Continuation of therapy [ Time Frame: 3 months ]
    Patients will be asked if they are going to continue therapy. Reasons for therapy termination shall be recorded
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry
Official Title Benefit, Usage and Comfort of Treatment of OSA With a Mandibular Advancement Device: Narval Registry
Brief Summary During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Detailed Description During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.
Condition Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: April 18, 2019) 		250
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Prescription of a Narval CC mandibular advancement device
  • Age ≥ 18 years
  • Ability to understand the study information and information on usage of personal data
  • Signed and dated informed consent

Exclusion Criteria:

  • Patients with central sleep apnea (central AI > 5/hour)
  • Patients with loose teeth and severe parodontitis
  • Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Oliver Munt, PhD +491629056360 oliver.munt@resmed.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03924817
Other Study ID Numbers Narval_Reg_22032019
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party ResMed
Study Sponsor ResMed
Collaborators Not Provided
Investigators
Principal Investigator: Christoph Schoebel, Prof Ruhrlandklinik Essen
PRS Account ResMed
Verification Date May 2020

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