Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial

Conditions
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Resistant Hypertension, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous positive airway pressure<br> | Device: continuous positive airway pressure<br>* Use CPAP whenever sleep<br>* Other names: CPAP;|
| No Intervention: observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean systolic blood pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure |  | 8 weeks | 
| mean diastolic blood pressure |  | 8 weeks | 
| high sensitivity C-reactive protein |  | 8 weeks | 
| cardiac injury marker |  | 8 weeks | 
| oxidative stress marker |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, resistant hypertension, refractory hypertension, continuous positive airway pressure, blood pressure control