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

March 20, 2018 updated by: Dr. Stella Daskalopoulou, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: auto-titrating
Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
Device: APAP
6 weeks of treatment with auto-titrating positive airway pressure
Other Names:
  • auto-titrating airway pressure
Active Comparator: Fixed
Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
Device: CPAP
6 weeks treatment with fixed CPAP
Other Names:
  • Continuous Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour blood pressure.
Time Frame: 6 weeks and 12 weeks after initial intervention
6 weeks and 12 weeks after initial intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-invasive measures of arterial stiffness using applanation tonometry.
Time Frame: 6 weeks and 12 weeks after initial intervention
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
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
6 weeks and 12 weeks after initial intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

OSR Medical Inc.

Investigators

  • Principal Investigator: Stella S Daskalopoulou, MD, MSc, PHd, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: R John Kimoff, MD, FRCP(C), McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-038-SDR (SARHT 1001)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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