Back to resultsEffect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
Primary Purpose
Resistant Hypertension, Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPAP
APAP
Sponsored by
About this trial
This is an interventional treatment trial for Resistant Hypertension focused on measuring Resistant Hypertension, Obstructive Sleep Apnea, 24 Hour Blood Pressure, Arterial Stiffness, Insulin Resistance, CPAP, APAP
Eligibility Criteria
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
Sites / Locations
- Royal Victoria Hospital
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
auto-titrating
Fixed
Arm Description
Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
Outcomes
Primary Outcome Measures
24 hour blood pressure.
Secondary Outcome Measures
Non-invasive measures of arterial stiffness using applanation tonometry.
Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.
Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.
Full Information
NCT ID
NCT01044355
First Posted
January 6, 2010
Last Updated
March 20, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
OSR Medical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01044355
Brief Title
Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
OSR Medical Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension, Obstructive Sleep Apnea
Keywords
Resistant Hypertension, Obstructive Sleep Apnea, 24 Hour Blood Pressure, Arterial Stiffness, Insulin Resistance, CPAP, APAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
auto-titrating
Arm Type
Active Comparator
Arm Description
Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
Arm Title
Fixed
Arm Type
Active Comparator
Arm Description
Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
6 weeks treatment with fixed CPAP
Intervention Type
Device
Intervention Name(s)
APAP
Other Intervention Name(s)
auto-titrating airway pressure
Intervention Description
6 weeks of treatment with auto-titrating positive airway pressure
Primary Outcome Measure Information:
Title
24 hour blood pressure.
Time Frame
6 weeks and 12 weeks after initial intervention
Secondary Outcome Measure Information:
Title
Non-invasive measures of arterial stiffness using applanation tonometry.
Time Frame
6 weeks and 12 weeks after initial intervention
Title
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
Title
Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.
Time Frame
6 weeks and 12 weeks after initial intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella S Daskalopoulou, MD, MSc, PHd
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R John Kimoff, MD, FRCP(C)
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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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