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Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

NCT05371509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-11-10

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Remastered Sleep LLC

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Umesh Goswami, MBBS, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2024-12-10
Completion
2024-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371509 on ClinicalTrials.gov