Sleep ApneaNCT05320952
Muscle Strength Exercise and Sleep Apnea
A study testing WellO2 in people with Sleep Apnea, run by Turku University Hospital at 1 site in Finland.
Trial summary
Background: Obstructive sleep apnea is one of our common diseases and up to 80% of patients are estimated to be undiagnosed. Its main risk factors are overweight, age, male gender, menopause, small jaw, sedative medications / drugs and alcohol. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- WellO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 23 May 2022to 31 Aug 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Male:Famel 1:1
- AHI 10-29 / h
- working patients
Who cannot join
- Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy
- significant history of nasal, oral and pharyngeal disorders
- BMI> 40 kg / m2
- other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain insult, neuromuscular disease or pregnancy, and work disability.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku University Hospital, Division of Medicine, Dept of Pulmonary diseases and University of Turku, Sleep Research Centre
Turku, 20520
About this study
Official title: Effect of Upper Respiratory Muscle Strength Exercise on Sleep Apnea Using WellO2 Respiratory Exercise Device
Background:
Obstructive sleep apnea is one of our common diseases and up to 80% of patients are estimated to be undiagnosed. Its main risk factors are overweight, age, male gender, menopause, small jaw, sedative medications / drugs and alcohol. The most important treatment for sleep apnea is continuous positive airway pressure (CPAP). However, not all patients adapt or benefit from device therapy, and up to about 60% stop using the device. Underlying sleep apnea are mechanisms other than anatomical factors such as respiratory wake sensitivity, loop gain control function, and upper respiratory tract muscle activation response and efficiency. Depending on which of these mechanisms dominates as the cause of sleep apnea, the patient's phenotype may vary and CPAP device therapy may not be the correct form of treatment for all patients. Therefore, new targeted therapies should be developed.
The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases. WellO2 effectively exercises the power of the inspiratory muscles, increases the inspiratory muscles, reduces the feeling of dyspnea due to exertion, increases the economy of respiration and delays inhalation muscles. It is a drug-free treatment and easy to use. The use of the WellO2 ventilator has not been previously studied in sleep apnea patients.
Read the detailed description
Research objectives:
- Will AHI change after 3 months of use of WellO2 (PSG in the beginning and after 3 months)
- Will the participants get help with fatigue symptoms or quality of life (questionnaires)
- Is there a response to WellO2 treatment in AHI and symptoms of sleep apnea still after 3 months of WellO2 treatment washout (PSG 3 months after treatment discontinuation)
- Are the participants able to use the device (questionnaires)
Research design:
A clinical follow-up study in lung clinic sleep apnea patients who are not receiving any other form of sleep apnea treatment. The estimate for the recruitment phase is 6-12 months. The duration of the study is 6 months, of which the active phase with the WellO2 breathing apparatus is 3 months and the washout phase is 3 months after the end of treatment.
Material:
The study enrolled working sleep apnea patients aged 18 to 60 years (n = 50; M: N = 1: 1) with mild to moderate obstructive sleep apnea (AHI 10-29 / h). Exclusion criteria: Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy, significant history of nasal, oral and pharyngeal disorders, BMI> 40 kg / m2, other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain event, neuromuscular disease or pregnancy, and disability to work.
Methods:
Participants enrolled in the study will be selected from referrals coming to Turku University Hospital for pulmonary department due to sleep apnea. Participants are interviewed in a structured way and demographic and anthropometric data (gender, age, BMI, neck and waist circumference, smoking), sleep apnea symptoms, possible previous treatment attempts, and other known diseases and medications are collected from the interview and from the hospital's patient paper archive. Sleep apnea is examined by sleep polypomyography (polysomnography, PSG) at the beginning of the study, 3 months after WellO2 treatment, and 3 months after the end of treatment. Participants complete the following questionnaires: Epworth Sleepiness Scale (ESS), 12-item General Health Questionnaire (GHQ-12), Depression Survey (DEPS), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Sleep Apnea Symptom Survey, Satisfaction Survey. Measurements of maximal inspiratory pressure (MIP) and maximal expirium pressure (MEP) are used to assess muscle strength, and FEV1, FVC, FEV1 / FVC, and PEF are measured with a miniature spirometer to see the size of the large bronchi and possible bronchial obstruction.
The participant is instructed in the use of the WellO2 orally and in writing. The WellO2 device is used twice a day for 15 minutes at a time at a power corresponding to 30% of the participant's MEP / MIP value. The WellO2 comes with an accessory that records the times and times you have done, as well as the power with the help of a pressure sensor and a mobile assistant. The WellO2 device will continue to be used for a total of 3 months, followed by a second three-month follow-up period without the WellO2 device.
The primary endpoint is resolution of sleep apnea symptoms and PSG findings after 3 months of treatment. The secondary endpoint is whether the effect after 3 months of treatment is maintained after the next 3-month's washout phase.
Significance of the research:
The physiological causes of sleep apnea have been clarified thanks to research in recent years. Hyperbaric ventilator therapy is not suitable for everyone and new therapies are needed for these patients. So far, there is no cure for sleep apnea. The WellO2 breathing training device would be affordable and easy to use for properly targeted sleep apnea patients of all ages.
- Conditions
- Sleep Apnea
- Being tested
- WellO2
- Keywords
- sleep apnea, muscle strength exercise, WellO2, apnea hypopnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellO2Device
The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases.
| Study group | Role | What they receive |
|---|---|---|
| working sleep apnea patients | Experimental | 50 sleep apnea patients with mild to moderate sleep apnea using WellO2 device for three months Receives: Device: WellO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index, AHI
Change in AHI measured from polysomnogaphy in the beginning and after 3 month's of WellO2 treatment?
Measured: 3 months
Secondary outcomes (3)
Sleep apnea symptoms
Is there a change in the sleep apnea symptoms (ex. fatigue symptoms or quality of life) after the WellO2 treatment?
Measured: 3 months
Longterm benefits in AHI and symptoms of sleep apnea
Is there a change in AHI or sleep apnea symptoms due to the WellO2 treatment after 3 months of treatment washout?
Measured: 6 months
WellO2 device usability
Are the participants able to use the WellO2 device during the 3 month's intervention?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start23 May 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single group study with three months active phase followed by three months washout.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- WellO2 Oy, University of Turku
- Responsible party
- Sponsor
- Investigators
- Ulla Anttalainen, MD, PhD, Principal investigator, Turku University Hospital, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320952
- Sponsor's protocol ID
- TO5/004/22
- Status last verified
- May 2025
- First submitted
- 24 Feb 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PubMed 23589584Afsharpaiman S, Shahverdi E, Vahedi E, Aqaee H. Continuous Positive Airway Pressure Compliance in Patients with Obstructive Sleep Apnea. Tanaffos. 2016;15(1):25-30.
PubMed 27403175Dempsey JA, Xie A, Patz DS, Wang D. Physiology in medicine: obstructive sleep apnea pathogenesis and treatment--considerations beyond airway anatomy. J Appl Physiol (1985). 2014 Jan 1;116(1):3-12. doi: 10.1152/japplphysiol.01054.2013. Epub 2013 Nov 7.
PubMed 24201709Eckert DJ. Phenotypic approaches to obstructive sleep apnoea - New pathways for targeted therapy. Sleep Med Rev. 2018 Feb;37:45-59. doi: 10.1016/j.smrv.2016.12.003. Epub 2016 Dec 18.
PubMed 28110857Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.
PubMed 16506871Karsten M, Ribeiro GS, Esquivel MS, Matte DL. The effects of inspiratory muscle training with linear workload devices on the sports performance and cardiopulmonary function of athletes: A systematic review and meta-analysis. Phys Ther Sport. 2018 Nov;34:92-104. doi: 10.1016/j.ptsp.2018.09.004. Epub 2018 Sep 15.
PubMed 30261349Romer LM, McConnell AK. Specificity and reversibility of inspiratory muscle training. Med Sci Sports Exerc. 2003 Feb;35(2):237-44. doi: 10.1249/01.MSS.0000048642.58419.1E.
PubMed 12569211Romer LM, McConnell AK, Jones DA. Effects of inspiratory muscle training on time-trial performance in trained cyclists. J Sports Sci. 2002 Jul;20(7):547-62. doi: 10.1080/026404102760000053.
PubMed 12166881Turner LA, Tecklenburg-Lund SL, Chapman RF, Stager JM, Wilhite DP, Mickleborough TD. Inspiratory muscle training lowers the oxygen cost of voluntary hyperpnea. J Appl Physiol (1985). 2012 Jan;112(1):127-34. doi: 10.1152/japplphysiol.00954.2011. Epub 2011 Oct 6.
PubMed 21979803Al-Rammahi U, Soukka T, Malinen J, Happonen RP, Sovijarvi A, Anttalainen U. Three-month follow-up after discontinuation of steam-assisted respiratory muscle training in mild-to-moderate obstructive sleep apnea: an exploratory polysomnographic study. Sleep Med. 2026 Oct 17;149:109326. doi: 10.1016/j.sleep.2026.109326. Online ahead of print.
PubMed 42896454Al-Rammahi U, Soukka T, Malinen J, Happonen RP, Sovijarvi A, Anttalainen U. Effects of steam-assisted respiratory muscle training on sleep apnoea symptoms and pulmonary function in men and women: a pilot study. Sleep Breath. 2025 Sep 15;29(5):286. doi: 10.1007/s11325-025-03449-2.
PubMed 40952626
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Respiratory Muscle Strength Exercise on Sleep Apnea Using WellO2 Respiratory Exercise Device
- ClinicalTrials.gov ID
- NCT05320952
- Acronym / sponsor ID
- TO5/004/22
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, muscle strength exercise, WellO2, apnea hypopnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- WellO2 Oy, University of Turku
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 11 Apr 2022 (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.
Background:
Obstructive sleep apnea is one of our common diseases and up to 80% of patients are estimated to be undiagnosed. Its main risk factors are overweight, age, male gender, menopause, small jaw, sedative medications / drugs and alcohol. The most important treatment for sleep apnea is continuous positive airway pressure (CPAP). However, not all patients adapt or benefit from device therapy, and up to about 60% stop using the device. Underlying sleep apnea are mechanisms other than anatomical factors such as respiratory wake sensitivity, loop gain control function, and upper respiratory tract muscle activation response and efficiency. Depending on which of these mechanisms dominates as the cause of sleep apnea, the patient's phenotype may vary and CPAP device therapy may not be the correct form of treatment for all patients. Therefore, new targeted therapies should be developed.
The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases. WellO2 effectively exercises the power of the inspiratory muscles, increases the inspiratory muscles, reduces the feeling of dyspnea due to exertion, increases the economy of respiration and delays inhalation muscles. It is a drug-free treatment and easy to use. The use of the WellO2 ventilator has not been previously studied in sleep apnea patients.
Detailed description
Research objectives:
- Will AHI change after 3 months of use of WellO2 (PSG in the beginning and after 3 months)
- Will the participants get help with fatigue symptoms or quality of life (questionnaires)
- Is there a response to WellO2 treatment in AHI and symptoms of sleep apnea still after 3 months of WellO2 treatment washout (PSG 3 months after treatment discontinuation)
- Are the participants able to use the device (questionnaires)
Research design:
A clinical follow-up study in lung clinic sleep apnea patients who are not receiving any other form of sleep apnea treatment. The estimate for the recruitment phase is 6-12 months. The duration of the study is 6 months, of which the active phase with the WellO2 breathing apparatus is 3 months and the washout phase is 3 months after the end of treatment.
Material:
The study enrolled working sleep apnea patients aged 18 to 60 years (n = 50; M: N = 1: 1) with mild to moderate obstructive sleep apnea (AHI 10-29 / h). Exclusion criteria: Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy, significant history of nasal, oral and pharyngeal disorders, BMI> 40 kg / m2, other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain event, neuromuscular disease or pregnancy, and disability to work.
Methods:
Participants enrolled in the study will be selected from referrals coming to Turku University Hospital for pulmonary department due to sleep apnea. Participants are interviewed in a structured way and demographic and anthropometric data (gender, age, BMI, neck and waist circumference, smoking), sleep apnea symptoms, possible previous treatment attempts, and other known diseases and medications are collected from the interview and from the hospital's patient paper archive. Sleep apnea is examined by sleep polypomyography (polysomnography, PSG) at the beginning of the study, 3 months after WellO2 treatment, and 3 months after the end of treatment. Participants complete the following questionnaires: Epworth Sleepiness Scale (ESS), 12-item General Health Questionnaire (GHQ-12), Depression Survey (DEPS), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Sleep Apnea Symptom Survey, Satisfaction Survey. Measurements of maximal inspiratory pressure (MIP) and maximal expirium pressure (MEP) are used to assess muscle strength, and FEV1, FVC, FEV1 / FVC, and PEF are measured with a miniature spirometer to see the size of the large bronchi and possible bronchial obstruction.
The participant is instructed in the use of the WellO2 orally and in writing. The WellO2 device is used twice a day for 15 minutes at a time at a power corresponding to 30% of the participant's MEP / MIP value. The WellO2 comes with an accessory that records the times and times you have done, as well as the power with the help of a pressure sensor and a mobile assistant. The WellO2 device will continue to be used for a total of 3 months, followed by a second three-month follow-up period without the WellO2 device.
The primary endpoint is resolution of sleep apnea symptoms and PSG findings after 3 months of treatment. The secondary endpoint is whether the effect after 3 months of treatment is maintained after the next 3-month's washout phase.
Significance of the research:
The physiological causes of sleep apnea have been clarified thanks to research in recent years. Hyperbaric ventilator therapy is not suitable for everyone and new therapies are needed for these patients. So far, there is no cure for sleep apnea. The WellO2 breathing training device would be affordable and easy to use for properly targeted sleep apnea patients of all ages.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single group study with three months active phase followed by three months washout.
| Arm | Type | Receives |
|---|---|---|
| working sleep apnea patients | Experimental | Device: WellO250 sleep apnea patients with mild to moderate sleep apnea using WellO2 device for three months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Male:Famel 1:1
- AHI 10-29 / h
- working patients
Key exclusion criteria (4 listed)
- Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy
- significant history of nasal, oral and pharyngeal disorders
- BMI> 40 kg / m2
- other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain insult, neuromuscular disease or pregnancy, and work disability.
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 |
|---|---|---|
| WellO2The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases. | Device | working sleep apnea patients |
Primary outcome
Apnea-hypopnea index, AHI
Time frame: 3 months
Change in AHI measured from polysomnogaphy in the beginning and after 3 month's of WellO2 treatment?
3 secondary outcomes
Sleep apnea symptoms
Time frame: 3 months
Longterm benefits in AHI and symptoms of sleep apnea
Time frame: 6 months
WellO2 device usability
Time frame: 3 months
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 31 May 2025.
- Background: PubMed 23589584Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Background: PubMed 27403175Afsharpaiman S, Shahverdi E, Vahedi E, Aqaee H. Continuous Positive Airway Pressure Compliance in Patients with Obstructive Sleep Apnea. Tanaffos. 2016;15(1):25-30.
- Background: PubMed 24201709Dempsey JA, Xie A, Patz DS, Wang D. Physiology in medicine: obstructive sleep apnea pathogenesis and treatment--considerations beyond airway anatomy. J Appl Physiol (1985). 2014 Jan 1;116(1):3-12. doi: 10.1152/japplphysiol.01054.2013. Epub 2013 Nov 7.
- Background: PubMed 28110857Eckert DJ. Phenotypic approaches to obstructive sleep apnoea - New pathways for targeted therapy. Sleep Med Rev. 2018 Feb;37:45-59. doi: 10.1016/j.smrv.2016.12.003. Epub 2016 Dec 18.
- Background: PubMed 16506871Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.
- Background: PubMed 30261349Karsten M, Ribeiro GS, Esquivel MS, Matte DL. The effects of inspiratory muscle training with linear workload devices on the sports performance and cardiopulmonary function of athletes: A systematic review and meta-analysis. Phys Ther Sport. 2018 Nov;34:92-104. doi: 10.1016/j.ptsp.2018.09.004. Epub 2018 Sep 15.
- Background: PubMed 12569211Romer LM, McConnell AK. Specificity and reversibility of inspiratory muscle training. Med Sci Sports Exerc. 2003 Feb;35(2):237-44. doi: 10.1249/01.MSS.0000048642.58419.1E.
- Background: PubMed 12166881Romer LM, McConnell AK, Jones DA. Effects of inspiratory muscle training on time-trial performance in trained cyclists. J Sports Sci. 2002 Jul;20(7):547-62. doi: 10.1080/026404102760000053.
- Background: PubMed 21979803Turner LA, Tecklenburg-Lund SL, Chapman RF, Stager JM, Wilhite DP, Mickleborough TD. Inspiratory muscle training lowers the oxygen cost of voluntary hyperpnea. J Appl Physiol (1985). 2012 Jan;112(1):127-34. doi: 10.1152/japplphysiol.00954.2011. Epub 2011 Oct 6.
- Derived from this study: PubMed 42896454Al-Rammahi U, Soukka T, Malinen J, Happonen RP, Sovijarvi A, Anttalainen U. Three-month follow-up after discontinuation of steam-assisted respiratory muscle training in mild-to-moderate obstructive sleep apnea: an exploratory polysomnographic study. Sleep Med. 2026 Oct 17;149:109326. doi: 10.1016/j.sleep.2026.109326. Online ahead of print.
- Derived from this study: PubMed 40952626Al-Rammahi U, Soukka T, Malinen J, Happonen RP, Sovijarvi A, Anttalainen U. Effects of steam-assisted respiratory muscle training on sleep apnoea symptoms and pulmonary function in men and women: a pilot study. Sleep Breath. 2025 Sep 15;29(5):286. doi: 10.1007/s11325-025-03449-2.
- 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.
Ulla Anttalainen, MD, PhD principal investigator
Turku University Hospital, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WellO2 in people with Sleep Apnea, run by Turku University Hospital at 1 site in Finland.
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 4 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 31 May 2025. 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 Finland. 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?
Apnea-hypopnea index, AHI (time frame: 3 months). 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 NCT05320952, which also lists 11 linked publications.
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 31 May 2025.