Trial Outcomes & Findings for Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP (NCT NCT01355419)
NCT ID: NCT01355419
Last Updated: 2015-05-12
Results Overview
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
baseline and at 3 months
Results posted on
2015-05-12
Participant Flow
Participant milestones
| Measure |
Obstructive Sleep Apnea, CPAP
moderate to severe obstructive sleep apnea requiring CPAP therapy
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
142
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP
Baseline characteristics by cohort
| Measure |
Obstructive Sleep Apnea, CPAP
n=150 Participants
moderate to severe obstructive sleep apnea requiring CPAP therapy
|
|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and at 3 monthschange in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
Outcome measures
| Measure |
Obstructive Sleep Apnea, CPAP
n=142 Participants
moderate to severe obstructive sleep apnea requiring CPAP therapy
|
|---|---|
|
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
|
29 minutes
Standard Deviation 17
|
SECONDARY outcome
Timeframe: baseline and at 3 monthsChange in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy
Outcome measures
| Measure |
Obstructive Sleep Apnea, CPAP
n=142 Participants
moderate to severe obstructive sleep apnea requiring CPAP therapy
|
|---|---|
|
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
|
369 steps
Standard Deviation 157
|
Adverse Events
Obstructive Sleep Apnea, CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place