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

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ClinicalTrials.gov Identifier: NCT01044355
Recruitment Status : Active, not recruiting
First Posted : January 7, 2010
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
OSR Medical Inc.
Information provided by (Responsible Party):
Dr. Stella Daskalopoulou, McGill University Health Center

Tracking Information
First Submitted Date  ICMJE January 6, 2010
First Posted Date  ICMJE January 7, 2010
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2010)
24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01044355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2010)
  • Non-invasive measures of arterial stiffness using applanation tonometry. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]
  • 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 ]
  • Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Resistant Hypertension
  • Obstructive Sleep Apnea
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2010)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date January 2020
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01044355
Other Study ID Numbers  ICMJE 09-038-SDR (SARHT 1001)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Stella Daskalopoulou, McGill University Health Center
Study Sponsor  ICMJE McGill University Health Center
Collaborators  ICMJE OSR Medical Inc.
Investigators  ICMJE
Principal Investigator: Stella S Daskalopoulou, MD, MSc, PHd McGill University Health Center
Principal Investigator: R John Kimoff, MD, FRCP(C) McGill University Health Center
PRS Account McGill University Health Center
Verification Date March 2018

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