Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP
Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
1 other identifier
observational
150
1 country
1
Brief Summary
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 6, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedMay 12, 2015
April 1, 2015
4 years
May 6, 2011
February 20, 2015
April 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
baseline and at 3 months
Secondary Outcomes (1)
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
baseline and at 3 months
Study Arms (1)
obstructive sleep apnea, CPAP
moderate to severe obstructive sleep apnea requiring CPAP therapy
Eligibility Criteria
Moderate to severe OSA
You may qualify if:
- Moderate to severe OSA
- sleepy (sleepiness assessed by Epworth Sleepiness Scale)
- indication for CPAP therapy
You may not qualify if:
- narcolepsy
- age \< 18
- non sleepy Moderate to severe OSA
- no CPAP treatment required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU St Pierre
Brussels, 1000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Marie Bruyneel
- Organization
- CHU St Pierre
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Bruyneel, MD
CHU St Pierre
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chef de clinique adjoint
Study Record Dates
First Submitted
May 6, 2011
First Posted
May 18, 2011
Study Start
August 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 12, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-04