Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
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|ClinicalTrials.gov Identifier: NCT05371509|
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : September 13, 2023
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Snoring||Device: Myofunctional therapy (MT) nozzle Other: Placebo nozzle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study|
|Actual Study Start Date :||September 7, 2023|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
Experimental: 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
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.
Placebo Comparator: Placebo nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
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.
- Adherence to Therapy [ Time Frame: 60 days ]Patient will use nozzle consistently and as instructed while regularly reporting results
- Change in quality of life [ Time Frame: Baseline, Day 60 ]Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which has a score between 1 and 7 on five different domains. Higher mean scores are suggestive of worse quality of life.
- Change in Apnea Hypopnea Index [ Time Frame: Baseline, Day 60 ]Apnea Hypopnea Index measured by WatchPAT One device
- Myofunction Assessment [ Time Frame: Baseline, Day 60 ]Myofunction assessment including tongue strength and endurance measurements by IOPI device. This measurement is reported in kPa and seconds. A higher value on these measurements is suggestive of higher tongue strength and endurance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05371509
|Contact: Brandon Clapp||507-284-2122||Clapp.Brandon@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Brandon Clapp 507-284-2122 email@example.com|
|Principal Investigator: John Park, MD|
|Principal Investigator:||Umesh Goswami, MBBS, MD||Mayo Clinic|