Trial of Auto Continuous Positive Airway Pressure (CPAP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP
* Device: autoCPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fixed CPAP<br>subject will sleep with a fixed CPAP device at minimal pressure | Device: CPAP<br>* CPAP at 4 cm H2O<br>|
| Experimental: autoCPAP<br>the subject will sleep connected to an autoCPAP device | Device: autoCPAP<br>* autoCPAP working between 4 and 15 cm H2O<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained |  | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reasons for pressure increase and consequences of the increase on sleep continuity |  | one night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, CPAP, sleep apnea