Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Study Overview
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Brief Summary
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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.

Official Title
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Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Conditions
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Obstructive Sleep Apnea, Snoring

Intervention / Treatment
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* Device: Myofunctional therapy (MT) nozzle
* Other: Placebo nozzle


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofunctional therapy (MT) nozzle<br>Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily | Device: Myofunctional therapy (MT) nozzle<br>* 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.<br>|
| Placebo Comparator: Placebo nozzle<br>Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily | Other: Placebo nozzle<br>* The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Therapy | Patient will use nozzle consistently and as instructed while regularly reporting results | 60 days | 
| Change in quality of life | 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. | Baseline, Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea Hypopnea Index | Apnea Hypopnea Index measured by WatchPAT One device | Baseline, Day 60 | 
| Myofunction Assessment | 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. | Baseline, Day 60 |