Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759456
• Other study ID #: NIG 2/20
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Brno University Hospital
• Contact: Jakub Hnatiak, MSc.
• Phone: +420 532233123
• Email: Hnatiak.Jakub[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Changes from Baseline in Body composition at Week 12	Measure will be taken from InBody 370.	Baseline and Week 12
Primary	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
Primary	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
Primary	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	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
Secondary	Change from Baseline in Neck/Waist/Hip circumferences at Week 12	All circumferences will be measured by tape measure.	Baseline and Week 12
Secondary	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
Secondary	Change from Baseline in Forced Vital Capacity at Week 12	Measure will be taken from Spirometry.	Baseline and Week 12
Secondary	Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12	Measure will be taken from Spirometry.	Baseline and Week 12