Obstructive Sleep ApneaNCT05371509
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
A study testing Myofunctional therapy (MT) nozzle in people with Obstructive Sleep Apnea and Snoring, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Snoring
- What is being tested?
- Myofunctional therapy (MT) nozzle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants willing to travel to the Rochester area for the Speech and Language Pathologist exam
Who cannot join
- 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.
- Significant mental health comorbidities including history of psychogenic polydipsia, obsessive-compulsive behavior, current suicidal ideation and uncontrolled anxiety.
- Unable or unwilling to participate in study procedures.
- Previous upper airway surgeries significantly modifying upper airway anatomy.
Show all 9Show fewer
- Known congenital or acquired diseases significantly affecting upper airway anatomy.
- BMI >40 kg/m^2.
- Currently treating OSA with hypoglossal nerve stimulator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Obstructive Sleep Apnea, Snoring
- Being tested
- Myofunctional therapy (MT) nozzle, Placebo nozzle
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional therapy (MT) nozzleDevice
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 nozzleOther
The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional therapy (MT) nozzle | Experimental | Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily Receives: Device: Myofunctional therapy (MT) nozzle |
| Placebo nozzle | Placebo comparator | Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily Receives: Other: Placebo nozzle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Therapy
The was measured as the number of days subjects met their daily water consumption goal. Subjects were asked to hit their daily water consumption goal 5 days per week for 8 weeks.
Measured: 60 days
Change in Quality of Life
Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which assesses the quality of life in individuals with obstructive sleep apnea. It has a score between 1 and 7 on five different domains with total scores ranging from 7 to 42, with higher scores indicating a worse quality of life.
Measured: Baseline, Day 60
Secondary outcomes (5)
Change in Apnea Hypopnea Index (AHI)
The Apnea Hypopnea Index (AHI) assesses the severity of sleep apnea by measuring the number of apneas (complete cessation of breathing for at least 10 seconds) and hypopneas (partial reductions in airflow) that occur during an hour of sleep. For this study AHI was measured through use of the WatchPAT One device.
Measured: Baseline, Day 60
Change in Myofunction Assessment
Myofunction assessment was done using the Iowa Oral Performance Instrument (IOPI) which involves measuring the strength and endurance of the tongue which aids in the diagnosis and treatment of obstructive sleep apnea. The assessment is done on both the anterior (front) and posterior (back) side of the tongue and measured in kilopascals (kPa). Normal values range from 40-80 kPa, with higher values indicating higher tongue strength and endurance.
Measured: Baseline, Day 60
Change in Oxygen Saturation (SpO2)
SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood.
Measured: Baseline; 60 Days
Change in Snoring Intensity
Snoring intensity was measured through a questionnaire that was administered to the subject's bed partner that asked "Over the past few days, how would you describe your spouse/bed partner's snoring?" Scores ranged from -3 (worst) to +3 (best) with higher scores indicating lower snoring intensity.
Measured: Baseline; Day 60
Change in Snoring Frequency
Snoring Frequency was measured through a questionnaire that was administered to the subject's bed partner that asked "Over the past few days, how often did you notice your bed partner's snoring?" Scores ranged from -4 (worst) to +4 (best) with higher scores indicating lower snoring frequency.
Measured: Baseline; Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start7 Sep 2023
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Remastered Sleep LLC
- Responsible party
- Principal investigator, Umesh Goswami, Mayo Clinic
- Investigators
- Umesh Goswami, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371509
- Sponsor's protocol ID
- 22-001883
- Other IDs
- R43HL160368
- Status last verified
- Oct 2025
- First submitted
- 9 May 2022
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
- ClinicalTrials.gov ID
- NCT05371509
- Acronym / sponsor ID
- 22-001883
- Conditions
- Obstructive Sleep Apnea, Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Remastered Sleep LLC
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofunctional therapy (MT) nozzle | Experimental | Device: Myofunctional therapy (MT) nozzleSubjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily |
| Placebo nozzle | Placebo comparator | Other: Placebo nozzleSubjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Participants willing to travel to the Rochester area for the Speech and Language Pathologist exam
Key exclusion criteria (9 listed)
- 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.
- Significant mental health comorbidities including history of psychogenic polydipsia, obsessive-compulsive behavior, current suicidal ideation and uncontrolled anxiety.
- Unable or unwilling to participate in study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofunctional therapy (MT) nozzleWater 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. | Device | Myofunctional therapy (MT) nozzle |
| Placebo nozzleThe placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle. | Other | Placebo nozzle |
Primary outcome
Adherence to Therapy
Time frame: 60 days
The was measured as the number of days subjects met their daily water consumption goal. Subjects were asked to hit their daily water consumption goal 5 days per week for 8 weeks.
Change in Quality of Life
Time frame: Baseline, Day 60
Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which assesses the quality of life in individuals with obstructive sleep apnea. It has a score between 1 and 7 on five different domains with total scores ranging from 7 to 42, with higher scores indicating a worse quality of life.
5 secondary outcomes
Change in Apnea Hypopnea Index (AHI)
Time frame: Baseline, Day 60
Change in Myofunction Assessment
Time frame: Baseline, Day 60
Change in Oxygen Saturation (SpO2)
Time frame: Baseline; 60 Days
Change in Snoring Intensity
Time frame: Baseline; Day 60
Change in Snoring Frequency
Time frame: Baseline; Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umesh Goswami, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctional therapy (MT) nozzle in people with Obstructive Sleep Apnea and Snoring, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Therapy (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.