NCT01090297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

April 1, 2011

Enrollment Period

3 years

First QC Date

March 18, 2010

Last Update Submit

February 14, 2013

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea SyndromeBlood pressureContinuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Clinical blood pressure

    Before treatment, 4 months after treatment

Secondary Outcomes (2)

  • Pulse Wave Velocity

    Before treatment, 4 months after treatment

  • 24 hours Blood Pressure measure

    Before treatment, after 4 months of treatment

Study Arms (2)

Fixed pressure

ACTIVE COMPARATOR
Device: S8 Spirit 2Device: Somnosmart 2Device: Remstar Auto

Auto-adjusting pressure

ACTIVE COMPARATOR
Device: S8 Spirit 2Device: Somnosmart 2Device: Remstar Auto

Interventions

S8 Spirit 2DEVICE

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.

Auto-adjusting pressureFixed pressure
Somnosmart 2DEVICE

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.

Auto-adjusting pressureFixed pressure
Remstar AutoDEVICE

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.

Auto-adjusting pressureFixed pressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AGIR à Dom

Meylan, 38240, France

Location

Related Publications (1)

  • 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.

    PMID: 27091542DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2011-04

Locations

FR(1)