Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

NCT03205878 | Unknown

• 1 other identifier: S60283
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Physical Activity; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The proportion of patients with an increase > 1,000 steps per day

  After 3 months (end of telecoaching) and after 12 months

• The proportion of patients with > 7500 steps/day

  Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months

• Change in functional exercise capacity

  3 months and 12 months compared with baseline

• Change in daytime sleepiness

  3 months and 12 months compared with baseline

• Change in sleep quality

  3 months and 12 months compared with baseline

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients will receive standard care, being CPAP treatment

Device: CPAP

Intervention group

EXPERIMENTAL

Patients will receive CPAP and telecoaching

Other: Telecoaching; Device: CPAP

Interventions

Telecoaching OTHER

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.

Intervention group

CPAP DEVICE

Patients will receive CPAP according to standard care

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Motor Activity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Behavior; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share