ClinicalTrials.gg
Active, not recruitingNCT06905951OSAUpdated Oct 27, 2026

The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

An interventional study of Exercise in Obstructive Sleep Apnea (OSA), Snoring and Sleep Quality, sponsored by Case Western Reserve University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2024, registered Feb 2025).
Updated Oct 27, 2026Study completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 the detailed description

Outcomes will be measured using tone analysis, snoring recording apps, and oximeters.

02

Conditions studied

  • Obstructive Sleep Apnea (OSA)
  • Snoring
  • Sleep Quality

Keywords

  • OSA
  • Myotherapy
  • Myofunctional Exercises
  • Snoring
  • Sleep Apnea
  • Sleep Quality
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 34 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with mild, moderate, and severe OSA who rejected/failed CPAP or other therapeutic options will be invited to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Age lower than 18 or higher than 75.
  2. > 40
  3. Alcoholism or drug abuse
  4. A-fib, pacemaker, CHF, strokes, narcotics
  5. Neuromuscular disease
  6. Use of benzodiazepine hypnotics (may affect muscle tone)
  7. Restricted tongue movement
  8. Permanently blocked nose
  9. TMJ disorder.
  10. Lost to follow-up
  11. Gained or lost ≥5% of body weight during 3 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    App Group

    The mouth exercises are guided and tracked by a phone application.

    Other: Exercise

  • Active comparator
    Analog Group

    The exercise and tracking is done using paper forms.

    Other: Exercise

Interventions

  • OtherExercise

    Mouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility.

    Also known as: Myofunctional Mouth Exercise

06

What researchers measure

Primary outcomes

  1. 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. .

    Time frame: baseline and then monthly for 3 months.

  2. 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.

    Time frame: baseline and then monthly for 3 months.

  3. Belun Ring Oxygen Saturation under 70%

    Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2.

    Time frame: baseline and then monthly for 3 months.

  4. 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.

    Time frame: baseline and then monthly for 3 months.

  5. 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.

    Time frame: baseline and then monthly for 3 months.

Secondary outcomes

  1. 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.

    Time frame: baseline and monthly for 3 months.

  2. Tongue Elevation strength

    The Iowa Oral Performance Instrument, is a validated intraoral device that measures tongue elevation strength in kPa.

    Time frame: baseline and monthly for 3 months.

  3. Tongue Protrusion strength

    The Iowa Oral Performance Instrument is a validated intraoral device that measures tongue protrusion strength in kPa.

    Time frame: baseline and monthly for 3 months.

  4. Buccinator strength

    The Iowa Oral Performance Instrument is a validated intraoral device that measure the buccinator muscle strength in kPa.

    Time frame: baseline and monthly for 3 months.

  5. 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.

    Time frame: baseline and monthly for 3 months.

  6. 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.

    Time frame: baseline and monthly for 3 months.

  7. 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.

    Time frame: baseline and monthly for 3 months.

  8. 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.

    Time frame: baseline and monthly for 3 months.

  9. 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.

    Time frame: baseline and monthly for 3 months.

07

Study locations

1 site
  • Case Western Reserve University Dental Clinic - Orthodontics
    Cleveland, Ohio 44106, United States
08

References and documents

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 32464087 ↗
  • Baptista 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 35210182 ↗
  • Rueda 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 33141943 ↗
  • Guimaraes 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 19234106 ↗
  • Behrents 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 31256826 ↗
  • Gottlieb 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Study completion
Sep 30, 2026→Dec 30, 2026
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Study completion Sep 30, 2026→Dec 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06905951
Collaborators
American Association of Orthodontists Foundation
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Aug 26, 2024
Primary completion
Dec 6, 2025
Completion
Dec 30, 2026 (estimated)
Last update
Oct 27, 2026

Study contacts

Juan M Palomo, DDS, MSD
principal investigator · Case Western Reserve University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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