Obstructive Sleep ApneaNCT04759456
Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
A study testing Remotely-supervised rehabilitation program in people with Obstructive Sleep Apnea, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Remotely-supervised rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Oct 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- newly diagnosed obstructive sleep apnea
- Apnea-Hypopnea Index greater than 15 episodes/hour
- indicated for CPAP therapy
Who cannot join
- severe pulmonary hypertension
- severe heart valve disease
- COPD III or IV
- central sleep apnea
- chronic corticosteroid therapy
- long-term oxygen therapy
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Remotely-supervised rehabilitation program
- Keywords
- Remotely-supervised rehabilitation program, Apnea-Hypopnea Index, Telemonitoring, Telecoaching, Telerehabilitation, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely-supervised rehabilitation programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy. Receives: Other: Remotely-supervised rehabilitation program |
| Control group | No intervention | Participants will undergo individually titrated CPAP therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Changes from Baseline in Body composition at Week 12
Measure will be taken from InBody 370.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (5)
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.
Measured: Baseline and Week 12
Change from Baseline in Neck/Waist/Hip circumferences at Week 12
All circumferences will be measured by tape measure.
Measured: 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.
Measured: Baseline and Week 12
Change from Baseline in Forced Vital Capacity at Week 12
Measure will be taken from Spirometry.
Measured: Baseline and Week 12
Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12
Measure will be taken from Spirometry.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start25 Oct 2021
- Primary completion31 May 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Hnatiak, MSc., Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759456
- Sponsor's protocol ID
- NIG 2/20
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2021
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37721786
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
- ClinicalTrials.gov ID
- NCT04759456
- Acronym / sponsor ID
- NIG 2/20
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Remotely-supervised rehabilitation program, Apnea-Hypopnea Index, Telemonitoring, Telecoaching, Telerehabilitation, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Remotely-supervised rehabilitation programParticipants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy. |
| Control group | No intervention | –Participants will undergo individually titrated CPAP therapy. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- signed informed consent
- newly diagnosed obstructive sleep apnea
- Apnea-Hypopnea Index greater than 15 episodes/hour
- indicated for CPAP therapy
Key exclusion criteria (13 listed)
- severe pulmonary hypertension
- severe heart valve disease
- COPD III or IV
- central sleep apnea
- chronic corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remotely-supervised rehabilitation programInclude 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 | Other | Intervention group |
Primary outcome
Change from Baseline in Apnea-Hypopnea Index at Week 12
Time frame: Baseline and 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.
Change from Baseline in Epworth Sleepiness Scale Score at Week 12
Time frame: Baseline and 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.
Change from Baseline in SF-36 Questionnaire Score at Week 12
Time frame: Baseline and 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.
Changes from Baseline in Body composition at Week 12
Time frame: Baseline and Week 12
Measure will be taken from InBody 370.
Change from Baseline in 6 Minutes Walking Test at Week 12
Time frame: Baseline and Week 12
6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome.
Change from Baseline in Maximal Inspiratory Pressure at Week 12
Time frame: Baseline and 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.
Change from Baseline in Maximal Expiratory Pressure at Week 12
Time frame: Baseline and 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.
5 secondary outcomes
Change from Baseline in Oxygen Desaturation Index at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Neck/Waist/Hip circumferences at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Body Mass Index at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Forced Vital Capacity at Week 12
Time frame: Baseline and Week 12
Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 37721786Hnatiak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely-supervised rehabilitation program in people with Obstructive Sleep Apnea, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Apnea-Hypopnea Index at Week 12 (time frame: Baseline and Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.