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

Obstructive Sleep Apnea Syndrome Clinical Trial

— AgirSASadom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090297
• Other study ID #: AGIR-01
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: February 14, 2013
• Start date: September 2009
• Est. completion date: November 2012

Study information

• Verified date: April 2011
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	AGIR à Dom	Meylan

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical blood pressure		Before treatment, 4 months after treatment	No
Secondary	Pulse Wave Velocity		Before treatment, 4 months after treatment	No
Secondary	24 hours Blood Pressure measure		Before treatment, after 4 months of treatment	No