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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

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014