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Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03205878
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Physical Activity Obstructive Sleep Apnea Other: Telecoaching Device: CPAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. Change in steps per day after 3 months [ Time Frame: The change will be measured after 3 months ]
    Steps per day as measured by a step counter


Secondary Outcome Measures :
  1. The proportion of patients with an increase > 1,000 steps per day [ Time Frame: After 3 months (end of telecoaching) and after 12 months ]
  2. 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 ]
  3. Change in functional exercise capacity [ Time Frame: 3 months and 12 months compared with baseline ]
    6-minute walking distance

  4. Change in daytime sleepiness [ Time Frame: 3 months and 12 months compared with baseline ]
    Epworth Sleepiness Scale

  5. Change in sleep quality [ Time Frame: 3 months and 12 months compared with baseline ]
    Pittsburgh Sleep Quality Index

  6. Change in endothelial function [ Time Frame: 3 months and 12 months compared with baseline ]
    Endo-PAT 2000 measurement

  7. Change in body composition [ Time Frame: 3 months and 12 months compared with baseline ]
    Bodystat 1500 measurement

  8. Change in quality of life [ Time Frame: 3 months and 12 months compared with baseline ]
    SF-36 questionnaire

  9. Change in steps per day after 12 months [ Time Frame: The change will be measured after 12 months ]
    Steps per day as measured by a step counter



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03205878     History of Changes
Other Study ID Numbers: S60283
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases