An interventional study of Myofunctional therapy (MT) nozzle and Placebo nozzle in Obstructive Sleep Apnea and Snoring, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 43 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily
Other: Placebo 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.
The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
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.
Time frame: 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.
Time frame: Baseline, Day 60
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Day 60
| Milestone | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Started | 21 | 21 |
| Completed | 20 | 21 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
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.
| days | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Adherence to Therapy | 18.4 ± 16.4 | 26.1 ± 15.2 |
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.
| score on a scale | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Change in Quality of Life | -0.02 ± 1.74 | 0.34 ± 0.78 |
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.
| AHI | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) | -0.9 ± 6.3 | 2.7 ± 6.8 |
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.
| kPa | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| IOPI Anterior | 0.6 ± 6.2 | -1.3 ± 7.2 |
| IOPI Posterior | 1.3 ± 7.3 | 0.7 ± 7.0 |
SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood.
| percent of oxygen in blood | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Change in Oxygen Saturation (SpO2) | 0.37 ± 0.84 | -0.07 ± 1.00 |
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.
| score on a scale | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Change in Snoring Intensity | 0.38 ± 0.81 | 0.25 ± 1.04 |
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.
| score on a scale | Myofunctional therapy (MT) nozzle | Placebo nozzle |
|---|---|---|
| Change in Snoring Frequency | 0.65 ± 1.00 | 0.89 ± 1.90 |
Collected over Adverse events were collected from the time of informed consent through study completion, approximately 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Placebo nozzle | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Myofunctional Therapy (MT) Nozzle | Placebo Nozzle | Total |
|---|---|---|---|
| Mean | 58.6 ± 9.9 | 51.38 ± 10.23 | 55.0 ± 10.6 |
| Sex: Female, Male(Participants) | Myofunctional Therapy (MT) Nozzle | Placebo Nozzle | Total |
|---|---|---|---|
| Female | 13 | 6 | 19 |
| Male | 8 | 15 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Myofunctional Therapy (MT) Nozzle | Placebo Nozzle | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 20 | 20 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Myofunctional Therapy (MT) Nozzle | Placebo Nozzle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 19 | 18 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Myofunctional Therapy (MT) Nozzle | Placebo Nozzle | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2023 to primary completion in Dec 2024, 15 months.
Results were first posted in Nov 2025, 11 months after primary completion.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 15 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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