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NCT05371509 | Recruiting | Obstructive Sleep Apnea

Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Umesh Goswami

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 snoring.

Condition or disease

Obstructive Sleep Apnea

Snoring

Intervention/treatment

Myofunctional therapy (MT) nozzle

Placebo nozzle

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : Double
Primary Purpose : Treatment
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
Arm Intervention/treatment

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

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients with mild-moderate Obstructive Sleep Apnea and snoring.
  • 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
Exclusion Criteria
  • Individuals not diagnosed with Obstructive Sleep Apnea and snoring.
  • 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.
  • Unable or unwilling to participate in study procedures.
  • Previous upper airway surgeries significantly modifying upper airway anatomy such as UPPP, apnea surgeries, oral and throat cancer surgeries or radiation.
  • Known congenital or acquired diseases significantly affecting upper airway anatomy such as Down's Syndrome, oral and throat cancer.
  • BMI >40 kg/m^2.
  • Currently treating OSA with hypoglossal nerve stimulator.
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

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Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

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Locations

Recruiting

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905