Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355419
• Other study ID #: AK/10-07-45/3912
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: April 27, 2015
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Belgium	CHU St Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients	Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy	baseline and at 3 months	No