Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01355419
First received: May 6, 2011
Last updated: May 13, 2014
Last verified: May 2014

May 6, 2011
May 13, 2014
August 2010
August 2014   (final data collection date for primary outcome measure)
Total sleep time before and after CPAP therapy in obstructive sleep apnea patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
evaluated by actigraphy
Same as current
Complete list of historical versions of study NCT01355419 on ClinicalTrials.gov Archive Site
Evolution of Physical activity (number of steps/day, mean daily time spent in activities > 3 METs, and mean daily energy expenditure; in Kcal)before and after CPAP therapy in OSA patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
evaluated by actigraphy
Same as current
Not Provided
Not Provided
 
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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Moderate to severe OSA

Obstructive Sleep Apnea
Not Provided
obstructive sleep apnea, CPAP
moderate to severe obstructive sleep apnea requiring CPAP therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
September 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marie Bruyneel, MD 3225354219 marie_bruyneel@stpierre-bru.be
Contact: Nathalie Hutsebaut, MD 3225353444 nathalie_hutsebaut@stpierre-bru.be
Belgium
 
NCT01355419
AK/10-07-45/3912
No
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
Centre Hospitalier Universitaire Saint Pierre
Not Provided
Principal Investigator: Marie Bruyneel, MD CHU St Pierre
Centre Hospitalier Universitaire Saint Pierre
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP