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Trial of Auto Continuous Positive Airway Pressure (CPAP)

This study has been completed.
Sponsor:
Collaborator:
Cliniques universitaires Saint-Luc
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01064258
First received: February 4, 2010
Last updated: February 15, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
 Device: CPAP
Device: autoCPAP
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained [ Time Frame: one night ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • reasons for pressure increase and consequences of the increase on sleep continuity [ Time Frame: one night ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fixed CPAP
subject will sleep with a fixed CPAP device at minimal pressure
 Device: CPAP
CPAP at 4 cm H2O
Experimental: autoCPAP
the subject will sleep connected to an autoCPAP device
 Device: autoCPAP
autoCPAP working between 4 and 15 cm H2O

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064258

Locations
Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc
Investigators
Principal Investigator: Daniel Rodenstein, MD Cliniques universitaires Saint-Luc
  More Information

No publications provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daniel Rodenstein MD, Cliniques universitaires Saint-Luc
ClinicalTrials.gov Identifier: NCT01064258     History of Changes
Other Study ID Numbers: 2007/30MARS/67
Study First Received: February 4, 2010
Last Updated: February 15, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
treatment
CPAP
sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013