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Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

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ClinicalTrials.gov Identifier: NCT01355419
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
Study Start Date : August 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients [ Time Frame: baseline and at 3 months ]
    change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy


Secondary Outcome Measures :
  1. Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients [ Time Frame: baseline and at 3 months ]
    Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355419


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

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
First Posted: May 18, 2011    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015
Last Verified: April 2015

Keywords provided by Marie Bruyneel, 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 Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases