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 Sep 2026
- Phase
- Interventional
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 Sep 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
- Feb 2026
- First submitted
- 25 Feb 2025
- Last updated
- 22 Sep 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