Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

The purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Remotely-supervised rehabilitation program

Detailed Description

The intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy.

The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• signed informed consent
• newly diagnosed obstructive sleep apnea
• Apnea-Hypopnea Index greater than 15 episodes/hour
• indicated for CPAP therapy

Exclusion Criteria:

• severe pulmonary hypertension
• severe heart valve disease
• COPD III or IV
• central sleep apnea
• chronic corticosteroid therapy
• long-term oxygen therapy
• heart failure
• left ventricular ejection fraction lower than 40 %
• NYHA III or IV
• cerebrovascular disease
• psychiatric disease
• another type of obstructive sleep apnea treatment
• acute coronary syndrome in anamnesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.	Other: Remotely-supervised rehabilitation program; Include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy
No Intervention: Control group; Participants will undergo individually titrated CPAP therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Apnea-Hypopnea Index at Week 12	Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome.	Baseline and Week 12
Change from Baseline in Epworth Sleepiness Scale Score at Week 12	ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome.	Baseline and Week 12
Change from Baseline in SF-36 Questionnaire Score at Week 12	SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome.	Baseline and Week 12
Changes from Baseline in Body composition at Week 12	Measure will be taken from InBody 370.	Baseline and Week 12
Change from Baseline in 6 Minutes Walking Test at Week 12	6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome.	Baseline and Week 12
Change from Baseline in Maximal Inspiratory Pressure at Week 12	Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.	Baseline and Week 12
Change from Baseline in Maximal Expiratory Pressure at Week 12	Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Oxygen Desaturation Index at Week 12	Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.	Baseline and Week 12
Change from Baseline in Neck/Waist/Hip circumferences at Week 12	All circumferences will be measured by tape measure.	Baseline and Week 12
Change from Baseline in Body Mass Index at Week 12	BMI will be calculated of participant's current weight and height.	Baseline and Week 12
Change from Baseline in Forced Vital Capacity at Week 12	Measure will be taken from Spirometry.	Baseline and Week 12
Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12	Measure will be taken from Spirometry.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Telemonitoring; Telerehabilitation; CPAP; Apnea-Hypopnea Index; Remotely-supervised rehabilitation program; Telecoaching
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: NIG 2/20

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
• product manufactured in and exported from the U.S.: No