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

This study has been completed.
Sponsor:
Information provided by:
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01090297
First received: March 18, 2010
Last updated: February 14, 2013
Last verified: April 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulse Wave Velocity [ Time Frame: Before treatment, 4 months after treatment ] [ Designated as safety issue: No ]
  • 24 hours Blood Pressure measure [ Time Frame: Before treatment, after 4 months of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01090297

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

No publications provided

Responsible Party: Jean Louis PEPIN, CHU de Grenoble
ClinicalTrials.gov Identifier: NCT01090297     History of Changes
Other Study ID Numbers: AGIR-01
Study First Received: March 18, 2010
Last Updated: February 14, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Syndrome
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014