Trial of Auto Continuous Positive Airway Pressure (CPAP)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 1

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP; Device: autoCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01064258

2007/30MARS/67

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups

fixed CPAP

Active Comparator group

Description:

subject will sleep with a fixed CPAP device at minimal pressure

Treatment:

Device: CPAP

autoCPAP

Experimental group

Description:

the subject will sleep connected to an autoCPAP device

Treatment:

Device: autoCPAP