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.

Study Overview

• Status: Completed
• Conditions: Snoring; Obstructive Sleep Apnea
• Intervention / Treatment: Device: Myofunctional therapy (MT) nozzle; Other: Placebo nozzle

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Therapy	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.	60 days
Change in Quality of Life	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.	Baseline, Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apnea Hypopnea Index (AHI)	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.	Baseline, Day 60
Change in Myofunction Assessment	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.	Baseline, Day 60
Change in Oxygen Saturation (SpO2)	SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood.	Baseline; 60 Days
Change in Snoring Intensity	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.	Baseline; Day 60
Change in Snoring Frequency	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.	Baseline; Day 60

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Remastered Sleep LLC
• Investigators: Principal Investigator: Umesh Goswami, MBBS, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Respiratory Sounds; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea, Obstructive; Snoring; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Dentistry; Myofunctional Therapy
• Other Study ID Numbers: 22-001883; R43HL160368 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No