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出境医 / 临床实验 / Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Study Description
Brief Summary:
The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collection will be performed at the beginning of the study and at 3 months.

Condition or disease Intervention/treatment Phase
Normotensive Sleep Apnea, Obstructive Device: CPAP treatment Not Applicable

Detailed Description:
  1. Recruitment: Normotensive subjects referred to the sleep unit of the Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and dipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.

  2. Definition of the groups: Patients will be randomized to receive one of the following treatments:

    1. CPAP: Patients who will receive CPAP treatment. The CPAP titration will be carried out with an automatic or manual CPAP according to usual clinical practice.
    2. Conservative treatment: Patients who will receive conservative treatment based on hygienic-dietetic measures.
  3. Randomization: It will be carried out with an automated platform

  4. Duration of the treatment: All patients randomized to CPAP will begin treatment as soon as possible after randomization, and will continue treatment until the study ends (3 months).

    Patients who interrupt treatment will be excluded from the study. ABPM and blood sample collection will be performed on all included patients at the beginning of the study and at 3 months under treatment (CPAP or conservative care).

  5. Follow-up: All patients will be evaluated at the beginning of the study (T0), at first month (T1) and at three months (T2), during the follow-up period.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, parallel, prospective, randomized and controlled trial.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: CPAP treatment
Group of patients who will receive CPAP treatment
 Device: CPAP treatment
In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.
No Intervention: Conservative measures
Patients who will receive conservative treatment based on hygienic-dietetic measures
Outcome Measures
Primary Outcome Measures :
  1. Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA [ Time Frame: 3 years ]
    Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment


Secondary Outcome Measures :
  1. Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of normotensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18) [ Time Frame: 3 years ]
    The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data

  2. Relationship between compliance with CPAP treatment and the blood pressure change in these patients [ Time Frame: 3 years ]
    The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.

  3. Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment [ Time Frame: 3 years ]
    Using all the ABPM variables we will proceed to the identification of variables that are related to the change in mean nocturnal BP in patients treated with CPAP.

  4. Changes in the biomarkers' profile after CPAP treatment [ Time Frame: 3 years ]

    Using the the blood samples obtained in the baseline and 3 months visit it will be evaluated possible changes in the biomarkers profile after CPAP treatment.

    Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients representative of the change in BP in treated patients. The miRNAs associated with the change in BP will be identified from the 754 miRNAs potentially present in serum and plasma.

    Validation Phase: Specific primers will be designed for the real-time PCR amplification of the genes for which we have found a significant association The miRNAs found will be analyzed after 3 months of treatment. Analysis of biomarkers. Immunoassay techniques will evaluate the following markers before and after treatment: angiotensin I, II and III, plasma renin activity, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) and endogenous ouabain.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women over 18 years of age
  2. Referred to the sleep unit for suspected OSA
  3. Being normotensive and presenting an AHI ≥ 30 in the sleep study
  4. Signature of the informed consent.

Exclusion Criteria:

  1. Previous CPAP treatment
  2. Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18
  3. Psychophysical inability to complete questionnaires
  4. Previous diagnosis or suspicion of another sleep disorder
  5. Presence of more than 50% of central apneas or Cheyne-Stokes respiration
  6. Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases
  7. Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions
  8. Any medical, social or geographical factor that may endanger the patient's compliance 9-Having a profession of high risk (professional driver).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ferran Barbé Illa, MD +34 (973) 70 53 72 febarbe.lleida.ics@gencat.cat

Locations
Layout table for location information
Spain
Hospital Arnau de Vilanova-Santa Maria Recruiting
Lleida, Spain, 25198
Contact: Ferran Barbe, MD         
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Societat Catalana de Pneumologia
Investigators
Layout table for investigator information
Principal Investigator: Ferran Barbé Illa, MD SEPAR, CIBERES
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive dipper patients with severe OSA [ Time Frame: 3 years ]
Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		Effect of CPAP treatment on BP according to the circadian BP pattern in normotensive patients with severe OSA [ Time Frame: 3 years ]
Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of normotensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18) [ Time Frame: 3 years ]
    The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data
  • Relationship between compliance with CPAP treatment and the blood pressure change in these patients [ Time Frame: 3 years ]
    The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.
  • Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment [ Time Frame: 3 years ]
    Using all the ABPM variables we will proceed to the identification of variables that are related to the change in mean nocturnal BP in patients treated with CPAP.
  • Changes in the biomarkers' profile after CPAP treatment [ Time Frame: 3 years ]
    Using the the blood samples obtained in the baseline and 3 months visit it will be evaluated possible changes in the biomarkers profile after CPAP treatment. Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients representative of the change in BP in treated patients. The miRNAs associated with the change in BP will be identified from the 754 miRNAs potentially present in serum and plasma. Validation Phase: Specific primers will be designed for the real-time PCR amplification of the genes for which we have found a significant association The miRNAs found will be analyzed after 3 months of treatment. Analysis of biomarkers. Immunoassay techniques will evaluate the following markers before and after treatment: angiotensin I, II and III, plasma renin activity, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) and endogenous ouabain.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of normotensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18) [ Time Frame: 3 years ]
    The prevalence of each circadian patterns will be calculated from the baseline ambulatory blood pressure monitoring data
  • Relationship between compliance with CPAP treatment and the blood pressure change these patients [ Time Frame: 3 years ]
    The relation between CPAP compliance (mean hours per night) and change in mean nighttime BP using multivariate models in patients randomized to CPAP treatment.
  • Ambulatory blood pressure parameters different to circadian blood pressure that are related to the response to CPAP treatment [ Time Frame: 3 years ]
    Using all the ABPM variables we will proceed to the identification of variables that are related to the change in mean nocturnal BP in patients treated with CPAP.
  • Changes in the biomarkers' profile after CPAP treatment [ Time Frame: 3 years ]
    Using the the blood samples obtained in the baseline and 3 months visit it will be evaluated possible changes in the biomarkers profile after CPAP treatment. Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients Learning Phase: complete profile analysis (754 miRNAs) will be carried out in 24 patients representative of the change in BP in treated patients. The miRNAs associated with the change in BP will be identified from the 754 miRNAs potentially present in serum and plasma. Validation Phase: Specific primers will be designed for the real-time PCR amplification of the genes for which we have found a significant association The miRNAs found will be analyzed after 3 months of treatment. Analysis of biomarkers. Immunoassay techniques will evaluate the following markers before and after treatment: angiotensin I, II and III, plasma renin activity, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) and endogenous ouabain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern
Official Title  ICMJE CPAP Effect in Nocturnal Blood Pressure in Normotensive Patients With Dipper Circadian Pattern and Severe Obstructive Sleep Apnea (OSA)
Brief Summary The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collection will be performed at the beginning of the study and at 3 months.
Detailed Description
  1. Recruitment: Normotensive subjects referred to the sleep unit of the Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and dipper circadian blood pattern confirmed by ABPM and who do not present significant somnolence (Epworth≤18) will be included in the study.

  2. Definition of the groups: Patients will be randomized to receive one of the following treatments:

    1. CPAP: Patients who will receive CPAP treatment. The CPAP titration will be carried out with an automatic or manual CPAP according to usual clinical practice.
    2. Conservative treatment: Patients who will receive conservative treatment based on hygienic-dietetic measures.
  3. Randomization: It will be carried out with an automated platform

  4. Duration of the treatment: All patients randomized to CPAP will begin treatment as soon as possible after randomization, and will continue treatment until the study ends (3 months).

    Patients who interrupt treatment will be excluded from the study. ABPM and blood sample collection will be performed on all included patients at the beginning of the study and at 3 months under treatment (CPAP or conservative care).

  5. Follow-up: All patients will be evaluated at the beginning of the study (T0), at first month (T1) and at three months (T2), during the follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is an open-label, parallel, prospective, randomized and controlled trial.
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Normotensive
  • Sleep Apnea, Obstructive
Intervention  ICMJE Device: CPAP treatment
In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.
Study Arms  ICMJE
  • Experimental: CPAP treatment
    Group of patients who will receive CPAP treatment
    Intervention: Device: CPAP treatment
  • No Intervention: Conservative measures
    Patients who will receive conservative treatment based on hygienic-dietetic measures
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women over 18 years of age
  2. Referred to the sleep unit for suspected OSA
  3. Being normotensive and presenting an AHI ≥ 30 in the sleep study
  4. Signature of the informed consent.

Exclusion Criteria:

  1. Previous CPAP treatment
  2. Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18
  3. Psychophysical inability to complete questionnaires
  4. Previous diagnosis or suspicion of another sleep disorder
  5. Presence of more than 50% of central apneas or Cheyne-Stokes respiration
  6. Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases
  7. Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions
  8. Any medical, social or geographical factor that may endanger the patient's compliance 9-Having a profession of high risk (professional driver).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ferran Barbé Illa, MD +34 (973) 70 53 72 febarbe.lleida.ics@gencat.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948373
Other Study ID Numbers  ICMJE Dipper-OSA
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
Study Sponsor  ICMJE Sociedad Española de Neumología y Cirugía Torácica
Collaborators  ICMJE Societat Catalana de Pneumologia
Investigators  ICMJE
Principal Investigator: Ferran Barbé Illa, MD SEPAR, CIBERES
PRS Account Sociedad Española de Neumología y Cirugía Torácica
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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