Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study (NCT05371509) | Clinical Trial Compass
CompletedNot Applicable
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
United States43 participantsStarted 2023-09-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<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 hyp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.