Trial of Auto Continuous Positive Airway Pressure (CPAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
CPAP
autoCPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring treatment, CPAP, sleep apnea
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
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
fixed CPAP
autoCPAP
Arm Description
subject will sleep with a fixed CPAP device at minimal pressure
the subject will sleep connected to an autoCPAP device
Outcomes
Primary Outcome Measures
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
Secondary Outcome Measures
reasons for pressure increase and consequences of the increase on sleep continuity
Full Information
NCT ID
NCT01064258
First Posted
February 4, 2010
Last Updated
February 15, 2010
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc
1. Study Identification
Unique Protocol Identification Number
NCT01064258
Brief Title
Trial of Auto Continuous Positive Airway Pressure (CPAP)
Official Title
Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
treatment, CPAP, sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fixed CPAP
Arm Type
Active Comparator
Arm Description
subject will sleep with a fixed CPAP device at minimal pressure
Arm Title
autoCPAP
Arm Type
Experimental
Arm Description
the subject will sleep connected to an autoCPAP device
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP at 4 cm H2O
Intervention Type
Device
Intervention Name(s)
autoCPAP
Intervention Description
autoCPAP working between 4 and 15 cm H2O
Primary Outcome Measure Information:
Title
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
Time Frame
one night
Secondary Outcome Measure Information:
Title
reasons for pressure increase and consequences of the increase on sleep continuity
Time Frame
one night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rodenstein, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21632834
Citation
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.
Results Reference
derived
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Trial of Auto Continuous Positive Airway Pressure (CPAP)
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