Trial of Auto Continuous Positive Airway Pressure (CPAP)

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064258
• Other study ID #: 2007/30MARS/67
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2010
• Last updated: February 15, 2010
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
CPAP at 4 cm H2O
• autoCPAP
autoCPAP working between 4 and 15 cm H2O

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Cliniques universitaires Saint-Luc

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained		one night	Yes
Secondary	reasons for pressure increase and consequences of the increase on sleep continuity		one night	Yes