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Completed

NCT Number: NCT01355419

Sleep Schedules Modifications in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU St Pierre

Brussels, 1000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study title

Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 18, 2011
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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