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Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure (AgirSASadom)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090297
First Posted: March 19, 2010
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AGIR à Dom
  Purpose

Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.

Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.

Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.

Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.

2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.


Condition Intervention
Obstructive Sleep Apnea Syndrome Device: S8 Spirit 2 Device: Somnosmart 2 Device: Remstar Auto

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Clinical blood pressure [ Time Frame: Before treatment, 4 months after treatment ]

Secondary Outcome Measures:
  • Pulse Wave Velocity [ Time Frame: Before treatment, 4 months after treatment ]
  • 24 hours Blood Pressure measure [ Time Frame: Before treatment, after 4 months of treatment ]

Enrollment: 322
Study Start Date: September 2009
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fixed pressure Device: S8 Spirit 2

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.

Device: Somnosmart 2

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.

Device: Remstar Auto

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.

Active Comparator: Auto-adjusting pressure Device: S8 Spirit 2

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.

Device: Somnosmart 2

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.

Device: Remstar Auto

3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.

These 3 types of CPAP can be set in both mode of pressure.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 80 years
  • patients who gave written informed consent
  • patients who subscribed a social insurance
  • SAOS patients who need CPAP treatment.

Exclusion Criteria:

  • cardiac failure known and treated
  • central Apnea syndrome
  • patients who stopped CPAP treatment in the previous year
  • pregnant women
  • patients under guardianship
  • imprisoned patients, patients in hospital
  • patients included in an other clinical study
  Contacts and Locations
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): NCT01090297


Locations
France
AGIR à Dom
Meylan, France, 38240
Sponsors and Collaborators
AGIR à Dom
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Louis PEPIN, CHU de Grenoble
ClinicalTrials.gov Identifier: NCT01090297     History of Changes
Other Study ID Numbers: AGIR-01
First Submitted: March 18, 2010
First Posted: March 19, 2010
Last Update Posted: February 15, 2013
Last Verified: April 2011

Keywords provided by AGIR à Dom:
Obstructive Sleep Apnea Syndrome
Blood pressure
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases