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Active, Not Recruiting

NCT Number: NCT06905951

The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Snoring

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University Dental Clinic - Orthodontics

Cleveland, Ohio, 44106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Exercise

Other

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

Other names: Myofunctional Mouth Exercise

Primary outcomes

  1. Belun Ring Oxygen Saturation

    Time frame: baseline and then monthly for 3 months.

    Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome.

    .

  2. Belun Ring lowest Oxygen Saturation Level

    Time frame: baseline and then monthly for 3 months.

    Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage.

  3. Belun Ring Oxygen Saturation under 70%

    Time frame: baseline and then monthly for 3 months.

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

  4. Belun Ring AHI

    Time frame: baseline and then monthly for 3 months.

    Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep.

  5. Belun Ring Pulse Rate

    Time frame: baseline and then monthly for 3 months.

    Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range.

Secondary outcomes

  1. SnoreLab app

    Time frame: baseline and monthly for 3 months.

    A mobile phone app that records snoring when present, and categorizes into amount and level. Possible outcomes are: none, mild, moderate, severe, and epic.

  2. Tongue Elevation strength

    Time frame: baseline and monthly for 3 months.

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

  3. Tongue Protrusion strength

    Time frame: baseline and monthly for 3 months.

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

  4. Buccinator strength

    Time frame: baseline and monthly for 3 months.

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

  5. STOP-Bang Questionnaire

    Time frame: baseline and monthly for 3 months.

    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.

  6. Nasal Obstruction Assessment (NOSE) Questionnaire Score

    Time frame: baseline and monthly for 3 months.

    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.

  7. PROMIS Sleep Disturbance 8b Short Form Questionnaire

    Time frame: baseline and monthly for 3 months.

    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.

  8. Epworth Daytime Sleepiness Questionnaire

    Time frame: baseline and monthly for 3 months.

    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.

  9. PROMIS Sleep Impairment 8a Short Form Questionnaire

    Time frame: baseline and monthly for 3 months.

    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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • American Association of Orthodontists Foundation

Registry information

Official study title

The Impact Of Technology In The Myofunctional Therapy Treatment Of Obstructive Sleep Apnea Syndrome

Acronym: OSA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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