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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00881985

Collaborator

(none)

Enrollment

Location

Arms

124

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Resistant Hypertension Obstructive Sleep Apnea	Device: continuous positive airway pressure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: continuous positive airway pressure	Device: continuous positive airway pressure Use CPAP whenever sleep Other Names: CPAP
No Intervention: observation

Arm

Intervention/Treatment

Active Comparator: continuous positive airway pressure

Device: continuous positive airway pressure

Use CPAP whenever sleep

Other Names:

CPAP

No Intervention: observation

Outcome Measures

Primary Outcome Measures

mean systolic blood pressure [8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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