Trial of Auto Continuous Positive Airway Pressure (CPAP)

NCT ID: NCT01064258

Last Updated: 2010-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-10-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

fixed CPAP

subject will sleep with a fixed CPAP device at minimal pressure

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

CPAP at 4 cm H2O

autoCPAP

the subject will sleep connected to an autoCPAP device

Group Type: EXPERIMENTAL

autoCPAP

Intervention Type: DEVICE

autoCPAP working between 4 and 15 cm H2O

Interventions

CPAP

CPAP at 4 cm H2O

Intervention Type: DEVICE

autoCPAP

autoCPAP working between 4 and 15 cm H2O

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Cliniques universitaires Saint-Luc

Principal Investigators

Daniel Rodenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

References

Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510. No abstract available.

Reference Type: DERIVED

PMID: 21632834 (View on PubMed)

Other Identifiers

2007/30MARS/67

Identifier Type: -

Identifier Source: org_study_id