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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

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.


Condition or disease Intervention/treatment Phase
Resistant Hypertension Obstructive Sleep Apnea Device: CPAP Device: APAP Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 24 hour blood pressure. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]

Secondary Outcome Measures :
  1. Non-invasive measures of arterial stiffness using applanation tonometry. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]
  2. 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 ]
  3. Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin. [ Time Frame: 6 weeks and 12 weeks after initial intervention ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044355


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

Responsible Party: Dr. Stella Daskalopoulou, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01044355     History of Changes
Other Study ID Numbers: 09-038-SDR (SARHT 1001)
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Dr. Stella Daskalopoulou, McGill University Health Center:
Resistant Hypertension
Obstructive Sleep Apnea
24 Hour Blood Pressure
Arterial Stiffness
Insulin Resistance
CPAP
APAP

Additional relevant MeSH terms:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases