Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
OSR Medical Inc.
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01044355
First received: January 6, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 6, 2010
January 6, 2010
December 2009
January 2011   (final data collection date for primary outcome measure)
24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Non-invasive measures of arterial stiffness using applanation tonometry. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
  • Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
  • Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea

The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).

The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.

The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Resistant Hypertension
  • Obstructive Sleep Apnea
  • Device: CPAP
    6 weeks treatment with fixed CPAP
    Other Name: Continuous Positive Airway Pressure
  • Device: APAP
    6 weeks of treatment with auto-titrating positive airway pressure
    Other Name: auto-titrating airway pressure
  • Active Comparator: auto-titrating
    Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
    Intervention: Device: APAP
  • Active Comparator: Fixed
    Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
    Intervention: Device: CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Resistant Hypertension
  • Moderate Obstructive Sleep Apnea

Exclusion Criteria:

  • Creatinine >150 μmol/l
  • Systolic blood pressure > 170 mmHg
  • Diastolic blood pressure > 105 mmHg
  • Secondary cause of hypertension other than OSA
  • Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
  • Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications
Both
18 Years and older
No
Contact: Stella S Daskalopoulou, MD, MSc, PhD 514-934-1934 ext 42295 stella.daskalopoulou@mcgill.ca
Contact: Richard John Kimoff, MD, FRCP(C) 514-934-1934 ext 36117 john.kimoff@mcgill.ca
Canada
 
NCT01044355
09-038-SDR (SARHT 1001)
Yes
Dr. Stella Daskalopoulou, McGill University Health Center
McGill University Health Center
OSR Medical Inc.
Principal Investigator: Stella S Daskalopoulou, MD, MSc, PHd McGill University Health Center
Principal Investigator: R John Kimoff, MD, FRCP(C) McGill University Health Center
McGill University Health Center
January 2010

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