Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
NCT ID: NCT05371509
Last Updated: 2025-11-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
43 participants
INTERVENTIONAL
2023-09-07
2024-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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 nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 nozzle
The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Remastered Sleep LLC
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Umesh Goswami
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Umesh Goswami, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-001883
Identifier Type: -
Identifier Source: org_study_id