Status:
COMPLETED
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Remastered Sleep LLC
Conditions:
Obstructive Sleep Apnea
Snoring
Eligibility:
All Genders
18+ years
Phase:
NA
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 snorin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05371509
Start Date
September 7 2023
End Date
December 10 2024
Last Update
November 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905