The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

NCT06905951 | Active Not Recruiting

• 1 other identifier: STUDY20231615
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA); Sleep Quality; Snoring

Keywords

OSA; Myotherapy; Myofunctional Exercises; Snoring; Sleep Apnea; Sleep Quality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• SnoreLab app

  baseline and monthly for 3 months.

• Tongue Elevation strength

  baseline and monthly for 3 months.

• Tongue Protrusion strength

  baseline and monthly for 3 months.

• Buccinator strength

  baseline and monthly for 3 months.

• STOP-Bang Questionnaire

  baseline and monthly for 3 months.

Study Arms (2)

App Group

ACTIVE COMPARATOR

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

Other: Exercise

Analog Group

ACTIVE COMPARATOR

The exercise and tracking is done using paper forms.

Other: Exercise

Interventions

Exercise OTHER

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

Also known as: Myofunctional Mouth Exercise

Analog Group; App Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Restricted tongue movement
• Permanently blocked nose
• TMJ disorder.
• Lost to follow-up
• Gained or lost ≥5% of body weight during 3 months

Sponsors & Collaborators

• Case Western Reserve University: lead
• American Association of Orthodontists Foundation: collaborator

Study Sites (1)

Case Western Reserve University Dental Clinic - Orthodontics

Cleveland, Ohio, 44106, United States

Location

Related Publications (6)

• 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.

  PMID: 32464087 BACKGROUND

• 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.

  PMID: 35210182 BACKGROUND

• 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.

  PMID: 33141943 BACKGROUND

• 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.

  PMID: 19234106 BACKGROUND

• 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.

  PMID: 31256826 BACKGROUND

• 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.

  PMID: 32286648 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring; Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan M Palomo, DDS, MSD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: April 2, 2025
• Study Start: August 26, 2024
• Primary Completion: December 6, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)