Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Last updated: April 10, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Sleep Disorders

Sleep Apnea Syndromes

Treatment

Myofunctional therapy (MT) nozzle

Placebo nozzle

Clinical Study ID

NCT05371509
22-001883
R43HL160368
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with mild-moderate Obstructive Sleep Apnea and snoring.

  • Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29events/hour confirmed within last 2 years with an in-lab diagnostic polysomnographyor home sleep apnea test.

  • Ownership of a smartphone and willingness to use a smartphone application toautomatic log daily water intake.

  • Willingness and ability to discontinue the currently prescribed OSA treatment for atleast 3 days prior to testing.

  • Age greater than or equal to 18 years

Exclusion

Exclusion Criteria:

  • Individuals not diagnosed with Obstructive Sleep Apnea and snoring.

  • Significant weight change (10% change in body weight in Kg) from the time of the OSAdiagnosis until the study initiation.

  • Persistent excessive daytime sleepiness (Epworth Sleepiness scale > 10), despitetreatment 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.

  • Unable or unwilling to participate in study procedures.

  • Previous upper airway surgeries significantly modifying upper airway anatomy such asUPPP, apnea surgeries, oral and throat cancer surgeries or radiation.

  • Known congenital or acquired diseases significantly affecting upper airway anatomysuch as Down's Syndrome, oral and throat cancer.

  • BMI >40 kg/m^2.

  • Currently treating OSA with hypoglossal nerve stimulator.

Study Design

Total Participants: 43
Treatment Group(s): 2
Primary Treatment: Myofunctional therapy (MT) nozzle
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
December 10, 2024

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.