Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

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

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Obstructive Sleep Apnea
• Intervention / Treatment: Device: CPAP; Other: Telecoaching

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; Patients will receive standard care, being CPAP treatment	Device: CPAP; Patients will receive CPAP according to standard care
EXPERIMENTAL: Intervention group; Patients will receive CPAP and telecoaching	Device: CPAP; Patients will receive CPAP according to standard care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6-minute walking distance	3 months and 12 months compared with baseline
Change in daytime sleepiness	Epworth Sleepiness Scale	3 months and 12 months compared with baseline
Change in sleep quality	Pittsburgh Sleep Quality Index	3 months and 12 months compared with baseline
Change in endothelial function	Endo-PAT 2000 measurement	3 months and 12 months compared with baseline
Change in body composition	Bodystat 1500 measurement	3 months and 12 months compared with baseline
Change in quality of life	SF-36 questionnaire	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	The change will be measured after 12 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: S60283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No