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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • CHU St Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe OSA

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
obstructive sleep apnea, CPAP; moderate to severe obstructive sleep apnea requiring CPAP therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; sleep; Obstructive sleep apnea; CPAP; actigraphy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: AK/10-07-45/3912