Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Primary Purpose
Obstructive Sleep Apnea, Snoring
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Myofunctional therapy (MT) nozzle
Placebo nozzle
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patients with mild-moderate Obstructive Sleep Apnea and snoring.
Exclusion Criteria:
- Individuals not diagnosed with Obstructive Sleep Apnea and snoring.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Myofunctional therapy (MT) nozzle
Placebo nozzle
Arm Description
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
Outcomes
Primary Outcome Measures
Adherence to Therapy
Patient will use nozzle consistently and as instructed while regularly reporting results
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.
Secondary Outcome Measures
Change in Apnea Hypopnea Index
Apnea Hypopnea Index measured by WatchPAT One device
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.
Full Information
NCT ID
NCT05371509
First Posted
May 9, 2022
Last Updated
September 7, 2023
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Remastered Sleep LLC
1. Study Identification
Unique Protocol Identification Number
NCT05371509
Brief Title
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Official Title
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Remastered Sleep LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myofunctional therapy (MT) nozzle
Arm Type
Experimental
Arm Description
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily
Arm Title
Placebo nozzle
Arm Type
Placebo Comparator
Arm Description
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
Intervention Type
Device
Intervention Name(s)
Myofunctional therapy (MT) nozzle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo nozzle
Intervention Description
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 Measure Information:
Title
Adherence to Therapy
Description
Patient will use nozzle consistently and as instructed while regularly reporting results
Time Frame
60 days
Title
Change in quality of life
Description
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.
Time Frame
Baseline, Day 60
Secondary Outcome Measure Information:
Title
Change in Apnea Hypopnea Index
Description
Apnea Hypopnea Index measured by WatchPAT One device
Time Frame
Baseline, Day 60
Title
Myofunction Assessment
Description
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.
Time Frame
Baseline, Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Clapp
Phone
507-284-2122
Email
Clapp.Brandon@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umesh Goswami, MBBS, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Clapp
Phone
507-284-2122
Email
clapp.brandon@mayo.edu
First Name & Middle Initial & Last Name & Degree
John Park, MD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
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