Obstructive Sleep Apnea (OSA)OSANCT06905951
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
A study testing Exercise in people with Obstructive Sleep Apnea (OSA) and Snoring, run by Case Western Reserve University at 1 site in United States.
Trial summary
This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Snoring, Sleep Quality
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with mild, moderate, and severe OSA who rejected/failed CPAP or other therapeutic options will be invited to participate in the study.
Who cannot join
- Age lower than 18 or higher than 75.
- BMI > 40
- Alcoholism or drug abuse
- A-fib, pacemaker, CHF, strokes, narcotics
- Neuromuscular disease
- Use of benzodiazepine hypnotics (may affect muscle tone)
Show all 11Show fewer
- Restricted tongue movement
- Permanently blocked nose
- TMJ disorder.
- Lost to follow-up
- Gained or lost ≥5% of body weight during 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University Dental Clinic - Orthodontics
Cleveland, Ohio, 44106
About this study
Official title: The Impact Of Technology In The Myofunctional Therapy Treatment Of Obstructive Sleep Apnea Syndrome
This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.
Read the detailed description
Outcomes will be measured using tone analysis, snoring recording apps, and oximeters.
- Conditions
- Obstructive Sleep Apnea (OSA), Snoring, Sleep Quality
- Being tested
- Exercise
- Keywords
- OSA, Myotherapy, Myofunctional Exercises, Snoring, Sleep Apnea, Sleep Quality
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring, Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Myofunctional Mouth Exercise
Mouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility.
| Study group | Role | What they receive |
|---|---|---|
| App Group | Active comparator | The mouth exercises are guided and tracked by a phone application. Receives: Other: Exercise |
| Analog Group | Active comparator | The exercise and tracking is done using paper forms. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Belun Ring Oxygen Saturation
Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome.
.
Measured: baseline and then monthly for 3 months.
Belun Ring lowest Oxygen Saturation Level
Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage.
Measured: baseline and then monthly for 3 months.
Belun Ring Oxygen Saturation under 70%
Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2.
Measured: baseline and then monthly for 3 months.
Belun Ring AHI
Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep.
Measured: baseline and then monthly for 3 months.
Belun Ring Pulse Rate
Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range.
Measured: baseline and then monthly for 3 months.
Secondary outcomes (9)
SnoreLab app
A mobile phone app that records snoring when present, and categorizes into amount and level. Possible outcomes are: none, mild, moderate, severe, and epic.
Measured: baseline and monthly for 3 months.
Tongue Elevation strength
The Iowa Oral Performance Instrument, is a validated intraoral device that measures tongue elevation strength in kPa.
Measured: baseline and monthly for 3 months.
Tongue Protrusion strength
The Iowa Oral Performance Instrument is a validated intraoral device that measures tongue protrusion strength in kPa.
Measured: baseline and monthly for 3 months.
Buccinator strength
The Iowa Oral Performance Instrument is a validated intraoral device that measure the buccinator muscle strength in kPa.
Measured: baseline and monthly for 3 months.
STOP-Bang Questionnaire
STOP-Bang is a validated tool that determines if the subject is at no, low, moderate, or severe risk of sleep-apnea. It provides an objective score that ranges from 0 to 8.
Measured: baseline and monthly for 3 months.
Nasal Obstruction Assessment (NOSE) Questionnaire Score
NOSE is a validated tool that determines the level of difficulty that the subject experienced in breathing through their nose in the past 3 months. The questionnaire provides an objective score stating the risk level that ranges from 0 to 100 with lower scores indicating less nasal blockage and higher scores indicating worse nasal blockage.
Measured: baseline and monthly for 3 months.
PROMIS Sleep Disturbance 8b Short Form Questionnaire
Assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score that is then translated to a t-score with a mean of 50, std of 10.
Measured: baseline and monthly for 3 months.
Epworth Daytime Sleepiness Questionnaire
This is a validated tool that measures a person's daytime sleepiness and is commonly used to help diagnose sleep disorders. Eight prompts with each response scored from 0-3. Higher scores indicates greater sleepiness. It provides an objective score that can range from 0 to 24.
Measured: baseline and monthly for 3 months.
PROMIS Sleep Impairment 8a Short Form Questionnaire
Assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question usually has five response options ranging in value from one to five. Values are summed to generate a raw score which is then translated to a t-score with a mean of 50, std of 10.
Measured: baseline and monthly for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start26 Aug 2024
- Primary completion6 Dec 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Model description
- Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Responsible party
- Sponsor
- Investigators
- Juan M Palomo, DDS, MSD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905951
- Sponsor's protocol ID
- STUDY20231615
- Acronym
- OSA
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We intend to publish the results and make them available to the research community. Any additional data is available upon request and will be provided without any PHI.
Publications
Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.
PubMed 32464087Baptista PM, Martin F, Ross H, O'Connor Reina C, Plaza G, Casale M. A systematic review of smartphone applications and devices for obstructive sleep apnea. Braz J Otorhinolaryngol. 2022 Nov-Dec;88 Suppl 5(Suppl 5):S188-S197. doi: 10.1016/j.bjorl.2022.01.004. Epub 2022 Feb 4.
PubMed 35210182Rueda JR, Mugueta-Aguinaga I, Vilaro J, Rueda-Etxebarria M. Myofunctional therapy (oropharyngeal exercises) for obstructive sleep apnoea. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD013449. doi: 10.1002/14651858.CD013449.pub2.
PubMed 33141943Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.
PubMed 19234106Behrents RG, Shelgikar AV, Conley RS, Flores-Mir C, Hans M, Levine M, McNamara JA, Palomo JM, Pliska B, Stockstill JW, Wise J, Murphy S, Nagel NJ, Hittner J. Obstructive sleep apnea and orthodontics: An American Association of Orthodontists White Paper. Am J Orthod Dentofacial Orthop. 2019 Jul;156(1):13-28.e1. doi: 10.1016/j.ajodo.2019.04.009.
PubMed 31256826Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
PubMed 32286648
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Technology In The Myofunctional Therapy Treatment Of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT06905951
- Acronym / sponsor ID
- OSA / STUDY20231615
- Conditions
- Obstructive Sleep Apnea (OSA), Snoring, Sleep Quality
- Keywords
- OSA, Myotherapy, Myofunctional Exercises, Snoring, Sleep Apnea, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 6 Dec 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Apr 2025 (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.
This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.
Detailed description
Outcomes will be measured using tone analysis, snoring recording apps, and oximeters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.
| Arm | Type | Receives |
|---|---|---|
| App Group | Active comparator | Other: ExerciseThe mouth exercises are guided and tracked by a phone application. |
| Analog Group | Active comparator | Other: ExerciseThe exercise and tracking is done using paper forms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with mild, moderate, and severe OSA who rejected/failed CPAP or other therapeutic options will be invited to participate in the study.
Key exclusion criteria (11 listed)
- Age lower than 18 or higher than 75.
- BMI > 40
- Alcoholism or drug abuse
- A-fib, pacemaker, CHF, strokes, narcotics
- Neuromuscular disease
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 |
|---|---|---|
| ExerciseAlso: Myofunctional Mouth ExerciseMouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility. | Other | Analog Group, App Group |
Primary outcome
Belun Ring Oxygen Saturation
Time frame: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome. .
Belun Ring lowest Oxygen Saturation Level
Time frame: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage.
Belun Ring Oxygen Saturation under 70%
Time frame: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2.
Belun Ring AHI
Time frame: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep.
Belun Ring Pulse Rate
Time frame: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range.
9 secondary outcomes
SnoreLab app
Time frame: baseline and monthly for 3 months.
Tongue Elevation strength
Time frame: baseline and monthly for 3 months.
Tongue Protrusion strength
Time frame: baseline and monthly for 3 months.
Buccinator strength
Time frame: baseline and monthly for 3 months.
STOP-Bang Questionnaire
Time frame: baseline and monthly for 3 months.
Nasal Obstruction Assessment (NOSE) Questionnaire Score
Time frame: baseline and monthly for 3 months.
PROMIS Sleep Disturbance 8b Short Form Questionnaire
Time frame: baseline and monthly for 3 months.
Epworth Daytime Sleepiness Questionnaire
Time frame: baseline and monthly for 3 months.
PROMIS Sleep Impairment 8a Short Form Questionnaire
Time frame: baseline and monthly for 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 32464087Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.
- Background: PubMed 35210182Baptista PM, Martin F, Ross H, O'Connor Reina C, Plaza G, Casale M. A systematic review of smartphone applications and devices for obstructive sleep apnea. Braz J Otorhinolaryngol. 2022 Nov-Dec;88 Suppl 5(Suppl 5):S188-S197. doi: 10.1016/j.bjorl.2022.01.004. Epub 2022 Feb 4.
- Background: PubMed 33141943Rueda JR, Mugueta-Aguinaga I, Vilaro J, Rueda-Etxebarria M. Myofunctional therapy (oropharyngeal exercises) for obstructive sleep apnoea. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD013449. doi: 10.1002/14651858.CD013449.pub2.
- Background: PubMed 19234106Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.
- Background: PubMed 31256826Behrents RG, Shelgikar AV, Conley RS, Flores-Mir C, Hans M, Levine M, McNamara JA, Palomo JM, Pliska B, Stockstill JW, Wise J, Murphy S, Nagel NJ, Hittner J. Obstructive sleep apnea and orthodontics: An American Association of Orthodontists White Paper. Am J Orthod Dentofacial Orthop. 2019 Jul;156(1):13-28.e1. doi: 10.1016/j.ajodo.2019.04.009.
- Background: PubMed 32286648Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
- Individual participant dataSharing planned: No. We intend to publish the results and make them available to the research community. Any additional data is available upon request and will be provided without any PHI.
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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.
Juan M Palomo, DDS, MSD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obstructive Sleep Apnea (OSA) and Snoring, run by Case Western Reserve University at 1 site in United States.
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 1 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Belun Ring Oxygen Saturation (time frame: baseline and then monthly for 3 months.). The study lists 5 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 NCT06905951, which also lists 6 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 27 Oct 2026.