Clinical trial NCT06905951: The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Official title: The Impact Of Technology In The Myofunctional Therapy Treatment Of Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Snoring
Sleep Quality
Keywords: OSA
Myotherapy
Myofunctional Exercises
Snoring
Sleep Apnea
Sleep Quality
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: American Association of Orthodontists Foundation
First posted: 2025-04-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Belun Ring Oxygen Saturation
timeFrame: baseline and then monthly for 3 months.
measure: Belun Ring lowest Oxygen Saturation Level
timeFrame: baseline and then monthly for 3 months.
measure: Belun Ring Oxygen Saturation under 70%
timeFrame: baseline and then monthly for 3 months.
measure: Belun Ring AHI
timeFrame: baseline and then monthly for 3 months.
measure: Belun Ring Pulse Rate
timeFrame: baseline and then monthly for 3 months.
Secondary outcomes:
measure: SnoreLab app
timeFrame: baseline and monthly for 3 months.
measure: Tongue Elevation strength
timeFrame: baseline and monthly for 3 months.
measure: Tongue Protrusion strength
timeFrame: baseline and monthly for 3 months.
measure: Buccinator strength
timeFrame: baseline and monthly for 3 months.
measure: STOP-Bang Questionnaire
timeFrame: baseline and monthly for 3 months.
measure: Nasal Obstruction Assessment (NOSE) Questionnaire Score
timeFrame: baseline and monthly for 3 months.
measure: PROMIS Sleep Disturbance 8b Short Form Questionnaire
timeFrame: baseline and monthly for 3 months.
measure: Epworth Daytime Sleepiness Questionnaire
timeFrame: baseline and monthly for 3 months.
measure: PROMIS Sleep Impairment 8a Short Form Questionnaire
timeFrame: baseline and monthly for 3 months.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University Dental Clinic - Orthodontics
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Juan M Palomo, DDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.