Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

• ClinicalTrials.gov Identifier: NCT05371509
• Recruitment Status: Recruiting
• First Posted: May 12, 2022
• Last Update Posted: September 13, 2023
• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Remastered Sleep LLC
• Information provided by (Responsible Party): Umesh Goswami, Mayo Clinic

Study Description

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	Intervention/treatment	Phase
Obstructive Sleep Apnea; Snoring	Device: Myofunctional therapy (MT) nozzle; Other: Placebo nozzle	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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

Arms and Interventions

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; 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.

Outcome Measures

Primary Outcome Measures :

1. Adherence to Therapy [ Time Frame: 60 days ]
   Patient will use nozzle consistently and as instructed while regularly reporting results
2. 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.

Secondary Outcome Measures :

1. Change in Apnea Hypopnea Index [ Time Frame: Baseline, Day 60 ]
   Apnea Hypopnea Index measured by WatchPAT One device
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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.

Contacts and Locations

Contacts

Contact: Brandon Clapp; 507-284-2122; Clapp.Brandon@mayo.edu

Locations

United States, Minnesota

Mayo Clinic in Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Brandon Clapp 507-284-2122 clapp.brandon@mayo.edu

Principal Investigator: John Park, MD

Sponsors and Collaborators

Mayo Clinic

National Heart, Lung, and Blood Institute (NHLBI)

Remastered Sleep LLC

Investigators

• Principal Investigator: Umesh Goswami, MBBS, MD; Mayo Clinic

More Information

• Responsible Party: Umesh Goswami, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05371509
• Other Study ID Numbers: 22-001883; R43HL160368 ( U.S. NIH Grant/Contract )
• First Posted: May 12, 2022
• Last Update Posted: September 13, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Snoring; Respiration Disorders; Respiratory Tract Diseases; Dyssomnias; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory