Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Snoring
• Interventions: Device: Myofunctional therapy (MT) nozzle; Other: Placebo nozzle

• Registration Number: NCT05371509
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2023-09-07
• Status Verified: 2024-09
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

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

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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 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.
• Unable or unwilling to participate in study procedures.
• Previous upper airway surgeries significantly modifying upper airway anatomy such as UPPP, apnea surgeries, oral and throat cancer surgeries or radiation.
• Known congenital or acquired diseases significantly affecting upper airway anatomy such as Down's Syndrome, oral and throat cancer.
• BMI >40 kg/m^2.
• Currently treating OSA with hypoglossal nerve stimulator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myofunctional therapy (MT) nozzle	Myofunctional therapy (MT) nozzle	Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily
Placebo nozzle	Placebo nozzle	Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily

Primary Outcome Measures

Name	Time	Method
Adherence to Therapy	60 days	Patient will use nozzle consistently and as instructed while regularly reporting results
Change in quality of life	Baseline, Day 60	Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which has a score between 1 and 7 on five different domains. Higher mean scores are suggestive of worse quality of life.

Secondary Outcome Measures

Name	Time	Method
Change in Apnea Hypopnea Index	Baseline, Day 60	Apnea Hypopnea Index measured by WatchPAT One device
Myofunction Assessment	Baseline, Day 60	Myofunction assessment including tongue strength and endurance measurements by IOPI device. This measurement is reported in kPa and seconds. A higher value on these measurements is suggestive of higher tongue strength and endurance.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States