An interventional study of Telecoaching and CPAP in Physical Activity and Obstructive Sleep Apnea, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.
First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown.
The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 102 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive standard care, being CPAP treatment
Device: CPAP
Patients will receive CPAP and telecoaching
Other: Telecoaching · Device: CPAP
Patients in the intervention arm will receive a step counter and a cell phone with an app on which the amount of steps are daily sent to. Initial targets on steps per day will be discussed with the patient after an activity monitoring before the telecoaching procedure. Dependent whether the patient reaches his/her proposed goal each week, new goals are set.
Patients will receive CPAP according to standard care
Change in steps per day after 3 months
Steps per day as measured by a step counter
Time frame: The change will be measured after 3 months
The proportion of patients with an increase > 1,000 steps per day
Time frame: After 3 months (end of telecoaching) and after 12 months
The proportion of patients with > 7500 steps/day
Time frame: Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months
Change in functional exercise capacity
6-minute walking distance
Time frame: 3 months and 12 months compared with baseline
Change in daytime sleepiness
Epworth Sleepiness Scale
Time frame: 3 months and 12 months compared with baseline
Change in sleep quality
Pittsburgh Sleep Quality Index
Time frame: 3 months and 12 months compared with baseline
Change in endothelial function
Endo-PAT 2000 measurement
Time frame: 3 months and 12 months compared with baseline
Change in body composition
Bodystat 1500 measurement
Time frame: 3 months and 12 months compared with baseline
Change in quality of life
SF-36 questionnaire
Time frame: 3 months and 12 months compared with baseline
Change in steps per day after 12 months
Steps per day as measured by a step counter
Time frame: The change will be measured after 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven