Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01355419
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.

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. Sleep schemes and physical activity will be studied with actigraphy.

Study Design : prospective study. Number of patients supposed to be studied: 190

Methods:

Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index \> 20, and Epworth Sleepiness Scale Score(ESS) \>10 Ø Indication of CPAP therapy

Initial Evaluation :

* Phase 1

* ESS

* BMI

* Questionnaire : Nottingham health profile

* Comorbidities -medical therapy

* Smoking/alcohol Consumption

* Then, we give an Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days

* Phase 2

* Actigraphy report

* Start of CPAP therapy(pressure adjusted according to autoCPAP device report after minimum one night)

Second Evaluation, after 3 months under CPAP:

* Phase 1

§ ESS

* BMI

* CPAP observance report to calculate mean use/day

* Questionnaire : Nottingham health profile

* Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days

* Phase 2: after 1 week under CPAP and actigraphy

* Actigraphy report

* CPAP observance report

* CPAP Tolerance Questionnaire Ø

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-02-20
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Results First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Moderate to severe OSA
• sleepy (sleepiness assessed by Epworth Sleepiness Scale)
• indication for CPAP therapy

Exclusion Criteria

• narcolepsy
• age < 18
• non sleepy Moderate to severe OSA
• no CPAP treatment required

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients	baseline and at 3 months	change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy

Secondary Outcome Measures

Name	Time	Method
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients	baseline and at 3 months	Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy

Trial Locations

Locations (1)

CHU St Pierre; 🇧🇪 Brussels, Belgium