Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, CPAP, actigraphy, sleep, physical activity
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.
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
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients | baseline and at 3 months | change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients | baseline and at 3 months | Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obstructive Sleep Apnea, CPAP moderate to severe obstructive sleep apnea requiring CPAP therapy | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Obstructive Sleep Apnea, CPAP |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 10 |
| Region of Enrollment Belgium | 150 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
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
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obstructive Sleep Apnea, CPAP | Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients | 29 minutes | Standard Deviation 17 |
Comparison: A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.p-value: <0.05t-test, 2 sided
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
Time frame: baseline and at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obstructive Sleep Apnea, CPAP | Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients | 369 steps | Standard Deviation 157 |
Comparison: Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.p-value: <0.05Regression, Linear