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

Tracking Information

• First Submitted Date: May 9, 2022
• First Posted Date: May 12, 2022
• Last Update Posted Date: September 13, 2023
• Actual Study Start Date: September 7, 2023
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2023)

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

Original Primary Outcome Measures (submitted: May 9, 2022)

Adherence to [ Time Frame: 60 days ]

Number of subjects to complete the study using the myofunctional water bottle nozzel

Current Secondary Outcome Measures (submitted: September 7, 2023)

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

Original Secondary Outcome Measures (submitted: May 9, 2022)

Change in quality of life [ Time Frame: Baseline, 60 days ]

Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
• Official Title: Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Obstructive Sleep Apnea
• 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.

Study Arms

• 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
  Intervention: 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
  Intervention: Other: Placebo nozzle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 9, 2022): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05371509
• Other Study ID Numbers: 22-001883; R43HL160368 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Umesh Goswami, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current

Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)
• Remastered Sleep LLC

Investigators

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

• PRS Account: Mayo Clinic
• Verification Date: September 2023