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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obstructive sleep apnea, CPAP | moderate to severe obstructive sleep apnea requiring CPAP therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Moderate to severe OSA
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| Name | Affiliation | Role |
|---|---|---|
| Marie Bruyneel, MD | CHU St Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Brussels | 1000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Obstructive Sleep Apnea, CPAP | moderate to severe obstructive sleep apnea requiring CPAP therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obstructive Sleep Apnea, CPAP | moderate to severe obstructive sleep apnea requiring CPAP therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | minutes | baseline and at 3 months |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obstructive Sleep Apnea, CPAP | moderate to severe obstructive sleep apnea requiring CPAP therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie Bruyneel | CHU St Pierre | 00325354219 | Marie_BRUYNEEL@stpierre-bru.be |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | steps | baseline and at 3 months |
|
|
|
|
| 0 |
| 142 |
| 0 |
| 142 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |