Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

NCT05371509 | Completed Results FDA Device

• 2 other identifiers: 22-001883R43HL160368
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Snoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Apnea Hypopnea Index (AHI)

  Baseline, Day 60

• Change in Myofunction Assessment

  Baseline, Day 60

• Change in Oxygen Saturation (SpO2)

  Baseline; 60 Days

• Change in Snoring Intensity

  Baseline; Day 60

• Change in Snoring Frequency

  Baseline; Day 60

Study Arms (2)

Myofunctional therapy (MT) nozzle

EXPERIMENTAL

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

Placebo nozzle

PLACEBO COMPARATOR

Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily

Other: Placebo nozzle

Interventions

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.

Myofunctional therapy (MT) nozzle

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.

Placebo nozzle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Remastered Sleep LLC: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Results Point of Contact

• Title: Umesh Goswami, M.B.B.S., M.D.
• Organization: Mayo Clinic

goswami.umesh@mayo.edu

480-342-1137

Study Officials

• Umesh Goswami, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: September 7, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (1)