Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371509
• Other study ID #: 22-001883
• Secondary ID: R43HL160368
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: Brandon Clapp
• Phone: 507-284-2122
• Email: Clapp.Brandon[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Snoring

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI), Remastered Sleep LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Therapy	Patient will use nozzle consistently and as instructed while regularly reporting results	60 days
Primary	Change in quality of life	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.	Baseline, Day 60
Secondary	Change in Apnea Hypopnea Index	Apnea Hypopnea Index measured by WatchPAT One device	Baseline, Day 60
Secondary	Myofunction Assessment	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.	Baseline, Day 60

External Links

•   Mayo Clinic Clinical Trials