N/A
N=42
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Obstructive Sleep Apnea · Snoring
Bottom Line
View on ClinicalTrials.gov: NCT05371509 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Adherence to Therapy — 18.4; 26.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Myofunctional therapy (MT) nozzle (Device); Placebo nozzle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Therapy |
18.4; 26.1 | — |
| PRIMARY Change in Quality of Life |
-0.02; 0.34 | — |
| SECONDARY Change in Apnea Hypopnea Index (AHI) |
-0.9; 2.7 | — |
| SECONDARY Change in Myofunction Assessment |
0.6; -1.3; 1.3; 0.7 | — |
| SECONDARY Change in Oxygen Saturation (SpO2) |
0.37; -0.07 | — |
| SECONDARY Change in Snoring Intensity |
0.38; 0.25 | — |
| SECONDARY Change in Snoring Frequency |
0.65; 0.89 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT05371509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.