Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

Centre Hospitalier Universitaire Saint Pierre

Status: Completed

Conditions: Obstructive Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT01355419

AK/10-07-45/3912

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

obstructive sleep apnea, CPAP

Description:

moderate to severe obstructive sleep apnea requiring CPAP therapy