Trial of Auto Continuous Positive Airway Pressure (CPAP)

Phase 1

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP; Device: autoCPAP

• Registration Number: NCT01064258
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

Detailed Description

Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Last Update Submitted: 2010-02-15
• Last Update Posted: 2010-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• normal subject
• male and female
• age 18 to 65 years old

Exclusion Criteria

• obstructive sleep apnea
• unable to sleep with a CPAP device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fixed CPAP	CPAP	subject will sleep with a fixed CPAP device at minimal pressure
autoCPAP	autoCPAP	the subject will sleep connected to an autoCPAP device

Primary Outcome Measures

Name	Time	Method
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained	one night

Secondary Outcome Measures

Name	Time	Method
reasons for pressure increase and consequences of the increase on sleep continuity	one night

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium