Trial Outcomes & Findings for Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study (NCT NCT05371509)
NCT ID: NCT05371509
Last Updated: 2025-11-10
Results Overview
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.
COMPLETED
NA
43 participants
60 days
2025-11-10
Participant Flow
43 subjects were enrolled in the study and 1 subject withdrew prior to randomization.
Participant milestones
| Measure |
Myofunctional therapy (MT) nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Myofunctional therapy (MT) nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Baseline characteristics by cohort
| Measure |
Myofunctional Therapy (MT) Nozzle
n=21 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 Nozzle
n=21 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
51.38 years
STANDARD_DEVIATION 10.23 • n=20 Participants
|
55.0 years
STANDARD_DEVIATION 10.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
15 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=20 Participants
|
42 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 60 daysThe 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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=20 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=21 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Adherence to Therapy
|
18.4 days
Standard Deviation 16.4
|
26.1 days
Standard Deviation 15.2
|
PRIMARY outcome
Timeframe: Baseline, Day 60Population: Five subjects in the myofunctional therapy arm and 7 subjects in the placebo arm did not complete the SAQLI at both baseline and day 60, therefore the change in quality of life was unable to be reported for those subjects.
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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=15 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=14 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Quality of Life
|
-0.02 score on a scale
Standard Deviation 1.74
|
0.34 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline, Day 60Population: There was an error in the WatchPAT device data in 2 subjects in the Myofunction therapy arm and 5 in the placebo arm causing there to be no data for change in AHI for those subjects.
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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=18 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=16 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI)
|
-0.9 AHI
Standard Deviation 6.3
|
2.7 AHI
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, Day 60Population: 2 subjects in the placebo arm did not complete the myofunction assessment at both the baseline and day 60 visit therefore no data was available to calculate change in the myofunctional assessment for those subjects.
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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=20 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=19 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Myofunction Assessment
IOPI Anterior
|
0.6 kPa
Standard Deviation 6.2
|
-1.3 kPa
Standard Deviation 7.2
|
|
Change in Myofunction Assessment
IOPI Posterior
|
1.3 kPa
Standard Deviation 7.3
|
0.7 kPa
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline; 60 DaysPopulation: There was an error in the WatchPAT device data in 1 subject in the Myofunction therapy arm and 5 in the placebo arm causing there to be no data for change in SpO2 for those subjects.
SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=19 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=16 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Oxygen Saturation (SpO2)
|
0.37 percent of oxygen in blood
Standard Deviation 0.84
|
-0.07 percent of oxygen in blood
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline; Day 60Population: 4 subjects in the Myofunctional Therapy arm and 13 subjects in the placebo arm did not complete the snoring intensity question at both the baseline and day 60 visit therefore no data was available to calculate change in the snoring intensity for those subjects.
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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=16 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=8 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Snoring Intensity
|
0.38 score on a scale
Standard Deviation 0.81
|
0.25 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline; Day 60Population: 3 subjects in the Myofunctional Therapy arm and 12 subjects in the placebo arm did not complete the snoring frequency question at both the baseline and day 60 visit therefore no data was available to calculate change in the snoring frequency for those subjects.
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.
Outcome measures
| Measure |
Myofunctional therapy (MT) nozzle
n=17 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea received a water bottle with a myofunctional therapy (MT) nozzle to use daily
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 nozzle
n=9 Participants
Subjects diagnosed with mild to moderate obstructive sleep apnea receivede a water bottle with a placebo nozzle to use daily
Placebo nozzle: The placebo bottle nozzle looked similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
|
|---|---|---|
|
Change in Snoring Frequency
|
0.65 score on a scale
Standard Deviation 1.00
|
0.89 score on a scale
Standard Deviation 1.90
|
Adverse Events
Myofunctional therapy (MT) nozzle
Placebo nozzle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place