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The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity application of eXciteOSA | Experimental | Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. |
|
| High intensity application of eXciteOSA | Active Comparator | Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eXciteOSA | Device | eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Days Device Was Used | Adherence level will be reported as the mean number of days the eXciteOSA device was used. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Respiratory Event Index (REI) | The mean respiratory event index (events/hr) will be evaluated using a home sleep apnea test. A higher respiratory event index (REI) indicates greater frequency of abnormal breathing during sleep. | Up to 6 weeks |
| Epworth Sleepiness Scale (ESS) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naresh Punjabi, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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Patients with mild sleep apnea recruited from sleep clinic and general community
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Intensity Application of eXciteOSA | Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
| FG001 | High Intensity Application of eXciteOSA | Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Intensity Application of eXciteOSA | Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
| BG001 |
| 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 | Mean Number of Days Device Was Used | Adherence level will be reported as the mean number of days the eXciteOSA device was used. | Posted | Mean | Standard Deviation | Days | Up to 6 weeks |
|
6 weeks
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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 | Low Intensity Application of eXciteOSA | Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naresh M. Punjabi, MD, PhD | University of Miami, Miller School of Medicine | 305-243-6388 | npunjabi@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2023 | Sep 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Self-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness. |
| Up to 6 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | Self-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality. | Up to 6 weeks |
| Short Form-20 (SF-20) Scores | Self reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life. | Up to 6 weeks |
| Quality of Life as Measured by EuroQol Score | Self-reported quality of life based on the EuroQoL has a total score ranging from 0 to 100 with the higher score indicating better quality of life | Up to 6 weeks |
| Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | Self-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities. | Up to 6 weeks |
| Snoring Visual Analog Scores | Partner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring. | Up to 6 weeks |
| Number of Participants Accepting Long Term Treatment | Number of participants reporting acceptance of long term treatment will be reported | 6 weeks |
| High Intensity Application of eXciteOSA |
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Respiratory event index | Mean | Standard Deviation | events/hr |
|
| Epworth Sleepiness Scale | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Mean Respiratory Event Index (REI) | The mean respiratory event index (events/hr) will be evaluated using a home sleep apnea test. A higher respiratory event index (REI) indicates greater frequency of abnormal breathing during sleep. | Posted | Mean | Standard Deviation | events/hr | Up to 6 weeks |
|
|
|
| Secondary | Epworth Sleepiness Scale (ESS) Scores | Self-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Self-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Short Form-20 (SF-20) Scores | Self reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Quality of Life as Measured by EuroQol Score | Self-reported quality of life based on the EuroQoL has a total score ranging from 0 to 100 with the higher score indicating better quality of life | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | Self-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Snoring Visual Analog Scores | Partner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
| Secondary | Number of Participants Accepting Long Term Treatment | Number of participants reporting acceptance of long term treatment will be reported | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | High Intensity Application of eXciteOSA | Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. eXciteOSA: eXciteOSA is a device for improving genioglossus endurance through electrical stimulation | 0 | 21 | 0 | 21 | 0 | 21 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |