The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

NCT ID: NCT06905951

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2025-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea (OSA) Snoring Sleep Quality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both groups receive the same exercise prescription, but one is through a phone application and the other is a piece of paper.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

App Group

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Analog Group

The exercise and tracking is done using paper forms.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Myofunctional Mouth Exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Association of Orthodontists Foundation

UNKNOWN

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juan M Palomo, DDS, MSD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Case Western Reserve University Dental Clinic - Orthodontics

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Juan M Palomo, DDS, MSD

Role: CONTACT

1-216-368-2449

Brittney Sullivan, DDS

Role: CONTACT

1-216-368-3249

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Juan M Palomo, DDS, MSD

Role: primary

216-368-2449

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32464087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35210182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33141943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19234106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31256826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32286648 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY20231615

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myofunctional Therapy for Obstructive Sleep Apnea
NCT07301125 NOT_YET_RECRUITING NA
Low-Tech Treatments for Obstructive Sleep Apnea
NCT07301710 NOT_YET_RECRUITING PHASE1/PHASE2