Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03205878
• Other study ID #: S60283
• Status: Not yet recruiting
• Phase: N/A
• First received: June 28, 2017
• Last updated: June 29, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• AHI > 15 events/hour, measured by polysomnography

• < 7,500 steps per day

• Willing to start CPAP treatment

• Age between 18 and 65 years

• Signing the written informed consent

Exclusion Criteria:

• Patients with neuromuscular diseases

• Patients with chronic obstructive pulmonary disease and interstitial lung disease

• Patients with cardiac failure and ischemic heart failure

• Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity

• Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Physical Activity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Telecoaching
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.

Device:
• CPAP
Patients will receive CPAP according to standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in steps per day after 3 months	Steps per day as measured by a step counter	The change will be measured after 3 months
Secondary	The proportion of patients with an increase > 1,000 steps per day		After 3 months (end of telecoaching) and after 12 months
Secondary	The proportion of patients with > 7500 steps/day		Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months
Secondary	Change in functional exercise capacity	6-minute walking distance	3 months and 12 months compared with baseline
Secondary	Change in daytime sleepiness	Epworth Sleepiness Scale	3 months and 12 months compared with baseline
Secondary	Change in sleep quality	Pittsburgh Sleep Quality Index	3 months and 12 months compared with baseline
Secondary	Change in endothelial function	Endo-PAT 2000 measurement	3 months and 12 months compared with baseline
Secondary	Change in body composition	Bodystat 1500 measurement	3 months and 12 months compared with baseline
Secondary	Change in quality of life	SF-36 questionnaire	3 months and 12 months compared with baseline
Secondary	Change in steps per day after 12 months	Steps per day as measured by a step counter	The change will be measured after 12 months