Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

NCT ID: NCT03205878

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Activity Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Patients will receive standard care, being CPAP treatment

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Patients will receive CPAP according to standard care

Intervention group

Patients will receive CPAP and telecoaching

Group Type EXPERIMENTAL

Telecoaching

Intervention Type 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.

CPAP

Intervention Type DEVICE

Patients will receive CPAP according to standard care

Interventions

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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.

Intervention Type OTHER

CPAP

Patients will receive CPAP according to standard care

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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S60283

Identifier Type: -

Identifier Source: org_study_id

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