Obstructive Sleep Apnea, Snoring
Conditions
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.
Interventions
DEVICEMyofunctional 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.
OTHERPlacebo nozzle
The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Remastered Sleep LLC
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * Known congenital or acquired diseases significantly affecting upper airway anatomy. * BMI \>40 kg/m\^2. * Currently treating OSA with hypoglossal nerve stimulator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Therapy | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Myofunction Assessment | Baseline, Day 60 | 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. |
| Change in Snoring Intensity | Baseline; Day 60 | 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. |
| Change in Snoring Frequency | Baseline; Day 60 | 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. |
| Change in Oxygen Saturation (SpO2) | Baseline; 60 Days | SpO2 was measured using the WatchPat One device. SpO2 is a measurement of the percentage of oxygen-bound hemoglobin in the blood. |
| Change in Apnea Hypopnea Index (AHI) | Baseline, Day 60 | 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. |
Countries
United States
Participant flow
Pre-assignment details
43 subjects were enrolled in the study and 1 subject withdrew prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Myofunctional Therapy (MT) Nozzle | Total | Placebo Nozzle |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 9.9 | 55.0 years STANDARD_DEVIATION 10.6 | 51.38 years STANDARD_DEVIATION 10.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Region of Enrollment United States | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 13 Participants | 19 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Adherence to Therapy | 18.4 days | Standard Deviation 16.4 |
| Placebo nozzle | Adherence to Therapy | 26.1 days | Standard Deviation 15.2 |
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Quality of Life | -0.02 score on a scale | Standard Deviation 1.74 |
| Placebo nozzle | Change in Quality of Life | 0.34 score on a scale | Standard Deviation 0.78 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Apnea Hypopnea Index (AHI) | -0.9 AHI | Standard Deviation 6.3 |
| Placebo nozzle | Change in Apnea Hypopnea Index (AHI) | 2.7 AHI | Standard Deviation 6.8 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Myofunction Assessment | IOPI Posterior | 1.3 kPa | Standard Deviation 7.3 |
| Myofunctional therapy (MT) nozzle | Change in Myofunction Assessment | IOPI Anterior | 0.6 kPa | Standard Deviation 6.2 |
| Placebo nozzle | Change in Myofunction Assessment | IOPI Posterior | 0.7 kPa | Standard Deviation 7 |
| Placebo nozzle | Change in Myofunction Assessment | IOPI Anterior | -1.3 kPa | Standard Deviation 7.2 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Oxygen Saturation (SpO2) | 0.37 percent of oxygen in blood | Standard Deviation 0.84 |
| Placebo nozzle | Change in Oxygen Saturation (SpO2) | -0.07 percent of oxygen in blood | Standard Deviation 1 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Snoring Frequency | 0.65 score on a scale | Standard Deviation 1 |
| Placebo nozzle | Change in Snoring Frequency | 0.89 score on a scale | Standard Deviation 1.9 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Change in Snoring Intensity | 0.38 score on a scale | Standard Deviation 0.81 |
| Placebo nozzle | Change in Snoring Intensity | 0.25 score on a scale | Standard Deviation 1.04 |