Trial of Auto Continuous Positive Airway Pressure (CPAP)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064258

Enrollment

Registered

2010-02-08

Start date

2009-08-31

Completion date

2009-10-31

Last updated

2010-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

treatment, CPAP, sleep apnea

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.

Interventions

DEVICECPAP

CPAP at 4 cm H2O

DEVICEautoCPAP

autoCPAP working between 4 and 15 cm H2O

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
reasons for pressure increase and consequences of the increase on sleep continuity	one night

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026