The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy (OSA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Snoring; Sleep Quality; Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Other: Exercise

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

1. Age lower than 18 or higher than 75.
2. BMI > 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: App Group; The mouth exercises are guided and tracked by a phone application.	Other: Exercise; Mouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility.; Other Names: Myofunctional Mouth Exercise
Active Comparator: Analog Group; The exercise and tracking is done using paper forms.	Other: Exercise; Mouth, tongue, and throat exercise to strengthen the airway, reducing its collapsibility.; Other Names: Myofunctional Mouth Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. .	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.	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.	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.	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.	baseline and then monthly for 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline and monthly for 3 months.

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: American Association of Orthodontists Foundation
• Investigators: Principal Investigator: Juan M Palomo, DDS, MSD, Case Western Reserve University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): December 6, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: OSA; Sleep Apnea; Sleep Quality; Snoring; Myotherapy; Myofunctional Exercises
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Respiratory Sounds; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Snoring; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: STUDY20231615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No