An observational study in Obstructive Sleep Apnea, sponsored by Centre Hospitalier Universitaire Saint Pierre. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational
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
Phase 2
Second Evaluation, after 3 months under CPAP:
Phase 1
§ ESS
Phase 2: after 1 week under CPAP and actigraphy
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 150 is above the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate to severe OSA
Exclusion Criteria:
moderate to severe obstructive sleep apnea requiring CPAP therapy
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
Time frame: baseline and at 3 months
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy
Time frame: baseline and at 3 months
| Milestone | Obstructive Sleep Apnea, CPAP |
|---|---|
| Started | 150 |
| Completed | 142 |
| Not completed | 8 |
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
| minutes | Obstructive Sleep Apnea, CPAP |
|---|---|
| Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients | 29 ± 17 |
Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy
| steps | Obstructive Sleep Apnea, CPAP |
|---|---|
| Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients | 369 ± 157 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Obstructive Sleep Apnea, CPAP | — | 0/142 (0%) | 0/142 (0%) |
| Age, Continuous(years) | Obstructive Sleep Apnea, CPAP |
|---|---|
| Mean | 51 ± 10 |
| Age, Categorical(Participants) | Obstructive Sleep Apnea, CPAP |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 150 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Obstructive Sleep Apnea, CPAP |
|---|---|
| Female | 60 |
| Male | 90 |
| Region of Enrollment(participants) | Obstructive Sleep Apnea, CPAP |
|---|---|
| Belgium | 150 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Saint Pierre