Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

NCT04759456 | Active Not Recruiting

• 1 other identifier: NIG 2/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Remotely-supervised rehabilitation program; Apnea-Hypopnea Index; Telemonitoring; Telecoaching; Telerehabilitation; CPAP

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Change from Baseline in Oxygen Desaturation Index at Week 12

  Baseline and Week 12

• Change from Baseline in Neck/Waist/Hip circumferences at Week 12

  Baseline and Week 12

• Change from Baseline in Body Mass Index at Week 12

  Baseline and Week 12

• Change from Baseline in Forced Vital Capacity at Week 12

  Baseline and Week 12

• Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12

  Baseline and Week 12

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.

Other: Remotely-supervised rehabilitation program

Control group

NO INTERVENTION

Participants will undergo individually titrated CPAP therapy.

Interventions

Remotely-supervised rehabilitation program OTHER

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

Intervention group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 625 00, Czechia

Location

Related Publications (1)

• Hnatiak J, Zikmund Galkova L, Winnige P, Batalik L, Dosbaba F, Ludka O, Krejci J. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 18;12:e47460. doi: 10.2196/47460.

  PMID: 37721786 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: October 25, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)