Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

NCT ID: NCT01355419

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-08-31

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

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

obstructive sleep apnea, CPAP

moderate to severe obstructive sleep apnea requiring CPAP therapy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

chef de clinique adjoint

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Bruyneel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St Pierre

Locations

CHU St Pierre

Brussels, , Belgium

Countries

Belgium

Other Identifiers

AK/10-07-45/3912

Identifier Type: -

Identifier Source: org_study_id