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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00881985
Enrollment
92
Registered
2009-04-16
Start date
2009-03-31
Completion date
2019-07-31
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Resistant Hypertension

Keywords

obstructive sleep apnea, resistant hypertension, refractory hypertension, continuous positive airway pressure, blood pressure control

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).

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.

Interventions

DEVICEcontinuous positive airway pressure

Use CPAP whenever sleep

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mean systolic blood pressure8 weeks

Secondary

MeasureTime frame
mean arterial blood pressure8 weeks
mean diastolic blood pressure8 weeks
high sensitivity C-reactive protein8 weeks
cardiac injury marker8 weeks
oxidative stress marker8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026