Phase
Condition
Sleep Disorders
Sleep Apnea Syndromes
Treatment
Myofunctional therapy (MT) nozzle
Placebo nozzle
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with mild-moderate Obstructive Sleep Apnea and snoring.
Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29events/hour confirmed within last 2 years with an in-lab diagnostic polysomnographyor home sleep apnea test.
Ownership of a smartphone and willingness to use a smartphone application toautomatic log daily water intake.
Willingness and ability to discontinue the currently prescribed OSA treatment for atleast 3 days prior to testing.
Age greater than or equal to 18 years
Exclusion
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 OSAdiagnosis until the study initiation.
Persistent excessive daytime sleepiness (Epworth Sleepiness scale > 10), despitetreatment 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 asUPPP, apnea surgeries, oral and throat cancer surgeries or radiation.
Known congenital or acquired diseases significantly affecting upper airway anatomysuch as Down's Syndrome, oral and throat cancer.
BMI >40 kg/m^2.
Currently treating OSA with hypoglossal nerve stimulator.
Study Design
Connect with a study center
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
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