- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00881985
Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension
September 30, 2019 updated by: The University of Hong Kong
Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial
The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes.
Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications.
Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT.
There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size.
We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China, 852
- Queen Mary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 - 65
- known hypertension on ≧ 3 anti-hypertensive drugs
- Apnea-hypopnea index ≧15
- able to give informed written consent
Exclusion Criteria:
- moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
- endocrine/renal/cardiac causes of secondary HT
- congestive heart failure and clinically fluid overloaded
- On drugs that elevates BP e.g. NSAID, steroid
- Non-compliance to anti-hypertensive medications
- Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
- Active inflammatory/infective conditions e.g. rheumatoid arthritis
- Excessive sleepiness that can be risky e.g. occupational driver, machine operator
- Modification/changes of anti-hypertensive regimen within 8 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: observation
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Active Comparator: continuous positive airway pressure
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Use CPAP whenever sleep
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean systolic blood pressure
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean arterial blood pressure
Time Frame: 8 weeks
|
8 weeks
|
mean diastolic blood pressure
Time Frame: 8 weeks
|
8 weeks
|
high sensitivity C-reactive protein
Time Frame: 8 weeks
|
8 weeks
|
cardiac injury marker
Time Frame: 8 weeks
|
8 weeks
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oxidative stress marker
Time Frame: 8 weeks
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary SM Ip, MD, The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7. doi: 10.1097/00004872-200112000-00022.
- Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
- Young T, Peppard P, Palta M, Hla KM, Finn L, Morgan B, Skatrud J. Population-based study of sleep-disordered breathing as a risk factor for hypertension. Arch Intern Med. 1997 Aug 11-25;157(15):1746-52.
- Pepperell JC, Ramdassingh-Dow S, Crosthwaite N, Mullins R, Jenkinson C, Stradling JR, Davies RJ. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Lancet. 2002 Jan 19;359(9302):204-10. doi: 10.1016/S0140-6736(02)07445-7.
- Becker HF, Jerrentrup A, Ploch T, Grote L, Penzel T, Sullivan CE, Peter JH. Effect of nasal continuous positive airway pressure treatment on blood pressure in patients with obstructive sleep apnea. Circulation. 2003 Jan 7;107(1):68-73. doi: 10.1161/01.cir.0000042706.47107.7a.
- Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.
- Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM. Resistant hypertension: diagnosis, evaluation, and treatment. A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008 Jun;51(6):1403-19. doi: 10.1161/HYPERTENSIONAHA.108.189141. Epub 2008 Apr 7.
- Grote L, Hedner J, Peter JH. Sleep-related breathing disorder is an independent risk factor for uncontrolled hypertension. J Hypertens. 2000 Jun;18(6):679-85. doi: 10.1097/00004872-200018060-00004.
- Lavie P, Hoffstein V. Sleep apnea syndrome: a possible contributing factor to resistant. Sleep. 2001 Sep 15;24(6):721-5. doi: 10.1093/sleep/24.6.721.
- Logan AG, Tkacova R, Perlikowski SM, Leung RS, Tisler A, Floras JS, Bradley TD. Refractory hypertension and sleep apnoea: effect of CPAP on blood pressure and baroreflex. Eur Respir J. 2003 Feb;21(2):241-7. doi: 10.1183/09031936.03.00035402.
- Martinez-Garcia MA, Gomez-Aldaravi R, Soler-Cataluna JJ, Martinez TG, Bernacer-Alpera B, Roman-Sanchez P. Positive effect of CPAP treatment on the control of difficult-to-treat hypertension. Eur Respir J. 2007 May;29(5):951-7. doi: 10.1183/09031936.00048606. Epub 2007 Feb 14.
- Lui MM, Tse HF, Lam DC, Lau KK, Chan CW, Ip MS. Continuous positive airway pressure improves blood pressure and serum cardiovascular biomarkers in obstructive sleep apnoea and hypertension. Eur Respir J. 2021 Nov 4;58(5):2003687. doi: 10.1183/13993003.03687-2020. Print 2021 Oct.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
April 14, 2009
First Submitted That Met QC Criteria
April 15, 2009
First Posted (Estimate)
April 16, 2009
Study Record Updates
Last Update Posted (Actual)
October 2, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 09-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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