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Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

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

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

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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05371509


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

Locations
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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
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Principal Investigator: Umesh Goswami, MBBS, MD Mayo Clinic
Additional Information:
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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    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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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