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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00881985
First received: April 14, 2009
Last updated: July 27, 2010
Last verified: July 2010
History of Changes

April 14, 2009
July 27, 2010
March 2009
December 2011   (final data collection date for primary outcome measure)
mean systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881985 on ClinicalTrials.gov Archive Site
  • mean arterial blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • mean diastolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • high sensitivity C-reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Resistant Hypertension
  • Obstructive Sleep Apnea
Device: continuous positive airway pressure
Use CPAP whenever sleep
Other Name: CPAP
  • Active Comparator: continuous positive airway pressure
    Intervention: Device: continuous positive airway pressure
  • No Intervention: observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Mary SM Ip, MD 852-28554455 msmip@hkucc.hku.hk
Contact: Macy MS Lui, MRCP 852-28553312 macylui@graduate.hku.hk
China
 
NCT00881985
UW 09-051
Not Provided
Professor Ip Sau Man Mary, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Mary SM Ip, MD The University of Hong Kong
The University of Hong Kong
July 2010

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