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| ID | Type | Description | Link |
|---|---|---|---|
| R43HL160368 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Remastered Sleep LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofunctional therapy (MT) nozzle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umesh Goswami, MBBS, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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43 subjects were enrolled in the study and 1 subject withdrew prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | days | 60 days |
|
Adverse events were collected from the time of informed consent through study completion, approximately 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Umesh Goswami, M.B.B.S., M.D. | Mayo Clinic | 480-342-1137 | goswami.umesh@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2024 | Oct 24, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2024 | Apr 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Placebo nozzle | Other | The placebo bottle nozzle will look similar to the MT nozzle; but is not expected to function the same as the MT nozzle. |
|
| 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. | 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. | 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. | 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. | Baseline; Day 60 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | AHI | Baseline, Day 60 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | kPa | Baseline, Day 60 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percent of oxygen in blood | Baseline; 60 Days |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 60 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 60 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |