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

CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: S8 Spirit 2; Device: Somnosmart 2; Device: Remstar Auto

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Meylan, France, 38240
    • AGIR à Dom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical blood pressure	Before treatment, 4 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulse Wave Velocity	Before treatment, 4 months after treatment
24 hours Blood Pressure measure	Before treatment, after 4 months of treatment

Collaborators and Investigators

• Sponsor: AGIR à Dom

Publications and helpful links

General Publications

• Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (Estimate): March 19, 2010

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Blood pressure; Obstructive Sleep Apnea Syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: AGIR-01