Clinical trial NCT01355419: Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP
Official title: Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
CPAP
actigraphy
sleep
physical activity
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe OSA

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

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

Primary outcomes:
measure: Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
timeFrame: baseline and at 3 months
Secondary outcomes:
measure: Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
timeFrame: baseline and at 3 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References: