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
Recruitment status was Recruiting
Sponsor:
McGill University Health Center
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Resistant Hypertension Obstructive Sleep Apnea |
Device: CPAP Device: APAP |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by McGill University Health Center:
Primary Outcome Measures:
- 24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 34 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Continuous Positive Airway Pressure
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044355
Contacts
| 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 |
Locations
| Canada, Quebec | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Principal Investigator: Stella S Daskalopoulou, MD, MSc, PhD | |
| Royal Victoria Hospital | Not yet recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Principal Investigator: Richard John Kimoff, MD, FRCP(C) | |
Sponsors and Collaborators
McGill University Health Center
OSR Medical Inc.
Investigators
| Principal Investigator: | Stella S Daskalopoulou, MD, MSc, PHd | McGill University Health Center |
| Principal Investigator: | R John Kimoff, MD, FRCP(C) | McGill University Health Center |
More Information
No publications provided
| Responsible Party: | Dr. Stella Daskalopoulou, McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT01044355 History of Changes |
| Other Study ID Numbers: | 09-038-SDR (SARHT 1001) |
| Study First Received: | January 6, 2010 |
| Last Updated: | January 6, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University Health Center:
|
Resistant Hypertension Obstructive Sleep Apnea 24 Hour Blood Pressure Arterial Stiffness |
Insulin Resistance CPAP APAP |
Additional relevant MeSH terms:
|
Apnea Hypertension Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Vascular Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013