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
  Purpose

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.


Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 142
Study Start Date: August 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
obstructive sleep apnea, CPAP
moderate to severe obstructive sleep apnea requiring CPAP therapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Moderate to severe OSA

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355419

Contacts
Contact: Marie Bruyneel, MD 3225354219 marie_bruyneel@stpierre-bru.be
Contact: Nathalie Hutsebaut, MD 3225353444 nathalie_hutsebaut@stpierre-bru.be

Locations
Belgium
CHU St Pierre Recruiting
Brussels, Belgium, 1000
Contact: bruyneel    3225354219      
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Marie Bruyneel, MD CHU St Pierre
  More Information

No publications provided

Responsible Party: Marie Bruyneel, chef de clinique adjoint, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01355419     History of Changes
Other Study ID Numbers: AK/10-07-45/3912
Study First Received: May 6, 2011
Last Updated: May 13, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Obstructive sleep apnea
CPAP
actigraphy
sleep
physical activity

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014