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Completed

NCT Number: NCT05371509

Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

This research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (MT) nozzle will improve obstructive sleep apnea and primary snoring.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias 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 Wake Disorders Snoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test.
  • Ownership of a smartphone and willingness to use a smartphone application to automatic log daily water intake.
  • Willingness and ability to discontinue the currently prescribed OSA treatment for at least 3 days prior to testing.
  • Age greater than or equal to 18 years.
  • Participants willing to travel to the Rochester area for the Speech and Language Pathologist exam

Exclusion criteria

  • Significant weight change (10% change in body weight in Kg) from the time of the OSA diagnosis until the study initiation.
  • Persistent excessive daytime sleepiness (Epworth Sleepiness scale > 10), despite treatment of OSA
  • Significant medical comorbidities requiring restricted oral fluid intake - decompensated heart failure, end stage renal disease, end stage liver disease, hyponatremia (S. Na <130 mg/dl), nocturia > times/night.
  • Significant mental health comorbidities including history of psychogenic polydipsia, obsessive-compulsive behavior, current suicidal ideation and uncontrolled anxiety.
  • Unable or unwilling to participate in study procedures.
  • Previous upper airway surgeries significantly modifying upper airway anatomy.
  • Known congenital or acquired diseases significantly affecting upper airway anatomy.
  • BMI >40 kg/m^2.
  • Currently treating OSA with hypoglossal nerve stimulator.

Treatment and study plan

Myofunctional therapy (MT) nozzle

Device

Water bottle nozzle designed to allow the user to repeatedly perform the tongue suction, tongue press, and swallow exercise movements while also providing targeted resistance to train and improve tongue, soft palate, and pharyngeal muscle strength and endurance.

Placebo nozzle

Other

The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.

Primary outcomes

  1. Adherence to Therapy

    Time frame: 60 days

    The was measured as the number of days subjects met their daily water consumption goal. Subjects were asked to hit their daily water consumption goal 5 days per week for 8 weeks.

  2. Change in Quality of Life

    Time frame: Baseline, Day 60

    Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which assesses the quality of life in individuals with obstructive sleep apnea. It has a score between 1 and 7 on five different domains with total scores ranging from 7 to 42, with higher scores indicating a worse quality of life.

Secondary outcomes

  1. Change in Apnea Hypopnea Index (AHI)

    Time frame: Baseline, Day 60

    The Apnea Hypopnea Index (AHI) assesses the severity of sleep apnea by measuring the number of apneas (complete cessation of breathing for at least 10 seconds) and hypopneas (partial reductions in airflow) that occur during an hour of sleep. For this study AHI was measured through use of the WatchPAT One device.

  2. Change in Myofunction Assessment

    Time frame: Baseline, Day 60

    Myofunction assessment was done using the Iowa Oral Performance Instrument (IOPI) which involves measuring the strength and endurance of the tongue which aids in the diagnosis and treatment of obstructive sleep apnea. The assessment is done on both the anterior (front) and posterior (back) side of the tongue and measured in kilopascals (kPa). Normal values range from 40-80 kPa, with higher values indicating higher tongue strength and endurance.

  3. Change in Oxygen Saturation (SpO2)

    Time frame: Baseline; 60 Days

    SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood.

  4. Change in Snoring Intensity

    Time frame: Baseline; Day 60

    Snoring intensity was measured through a questionnaire that was administered to the subject's bed partner that asked "Over the past few days, how would you describe your spouse/bed partner's snoring?" Scores ranged from -3 (worst) to +3 (best) with higher scores indicating lower snoring intensity.

  5. Change in Snoring Frequency

    Time frame: Baseline; Day 60

    Snoring Frequency was measured through a questionnaire that was administered to the subject's bed partner that asked "Over the past few days, how often did you notice your bed partner's snoring?" Scores ranged from -4 (worst) to +4 (best) with higher scores indicating lower snoring frequency.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Remastered Sleep LLC

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 12, 2022
Registry last updated
Nov 10, 2025

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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