Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Mayo Clinic

Status: Completed

Conditions: Snoring; Obstructive Sleep Apnea

Treatments: Device: Myofunctional therapy (MT) nozzle; Other: Placebo nozzle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05371509

22-001883

R43HL160368 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Myofunctional therapy (MT) nozzle

Experimental group

Description:

Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily

Treatment:

Device: Myofunctional therapy (MT) nozzle

Placebo nozzle

Placebo Comparator group

Description:

Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily

Treatment:

Other: Placebo nozzle