Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICEeXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years 2. Ability to consent 3. Home sleep apnea test demonstrating mild obstructive sleep apnea. 4. Smartphone or tablet
Exclusion criteria
1. Current pacemaker, defibrillator, or neuro-stimulation device 2. No prior oropharyngeal surgery for sleep apnea 3. No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity 4. No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP) 5. Heart failure (New York Heart Association Class 3 or 4; or ejection fraction \< 45%) 6. Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months 7. Uncontrolled hypertension (BP \> 160/100) 8. Clinician diagnosis of any chronic lung disease except asthma 9. Chronic fatigue syndrome or fibromyalgia 10. Self-reported current illicit drug use in the past 30 days 11. Self-reported use of marijuana or opiates in the past 30 days 12. Use of supplemental oxygen 13. Self-reported use of prescribed or over the counter sleeping medications in the past 30 days 14. Current pregnancy or intention of becoming pregnant 15. Oropharyngeal abnormalities (class 2 or class 3 malocclusion) 16. Periodic breathing (Cheyne Stoke respiration) 17. Central sleep apnea (central apnea index (CAI) \> 5/h) 18. Investigator discretion 19. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days Device Was Used | Up to 6 weeks | Adherence level will be reported as the mean number of days the eXciteOSA device was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Respiratory Event Index (REI) | Up to 6 weeks | 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. |
| Epworth Sleepiness Scale (ESS) Scores | Up to 6 weeks | Self-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness. |
| Pittsburgh Sleep Quality Index (PSQI) | Up to 6 weeks | Self-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality. |
| Number of Participants Accepting Long Term Treatment | 6 weeks | Number of participants reporting acceptance of long term treatment will be reported |
| Quality of Life as Measured by EuroQol Score | Up to 6 weeks | 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 |
| Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | Up to 6 weeks | Self-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities. |
| Snoring Visual Analog Scores | Up to 6 weeks | Partner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring. |
| Short Form-20 (SF-20) Scores | Up to 6 weeks | Self reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life. |
Countries
United States
Participant flow
Recruitment details
Patients with mild sleep apnea recruited from sleep clinic and general community
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Low Intensity Application of eXciteOSA | High Intensity Application of eXciteOSA |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 12.9 | 54.4 years STANDARD_DEVIATION 10.6 | 50.5 years STANDARD_DEVIATION 14.8 |
| Body Mass Index | 28.6 kg/m2 STANDARD_DEVIATION 4.8 | 28.9 kg/m2 STANDARD_DEVIATION 4.5 | 28.4 kg/m2 STANDARD_DEVIATION 5.2 |
| Epworth Sleepiness Scale | 9.3 units on a scale STANDARD_DEVIATION 5.6 | 10.3 units on a scale STANDARD_DEVIATION 5.3 | 8.2 units on a scale STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 17 Participants | 19 Participants |
| Respiratory event index | 12.3 events/hr | 12.0 events/hr STANDARD_DEVIATION 3.8 | 12.6 events/hr STANDARD_DEVIATION 3.7 |
| Sex: Female, Male Female | 17 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 23 Participants | 12 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Mean Number of Days Device Was Used
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Mean Number of Days Device Was Used | 38.0 Days | Standard Deviation 8.3 |
| High Intensity Application of eXciteOSA | Mean Number of Days Device Was Used | 38.4 Days | Standard Deviation 7.4 |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Epworth Sleepiness Scale (ESS) Scores | 9.4 score on a scale | Standard Deviation 5.4 |
| High Intensity Application of eXciteOSA | Epworth Sleepiness Scale (ESS) Scores | 6.9 score on a scale | Standard Deviation 4.3 |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Mean Respiratory Event Index (REI) | 12.6 events/hr | Standard Deviation 1.2 |
| High Intensity Application of eXciteOSA | Mean Respiratory Event Index (REI) | 9.6 events/hr | Standard Deviation 1.2 |
Secondary
Number of Participants Accepting Long Term Treatment
Number of participants reporting acceptance of long term treatment will be reported
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Intensity Application of eXciteOSA | Number of Participants Accepting Long Term Treatment | 0 Participants |
| High Intensity Application of eXciteOSA | Number of Participants Accepting Long Term Treatment | 0 Participants |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Pittsburgh Sleep Quality Index (PSQI) | 7.2 score on a scale | Standard Deviation 4.3 |
| High Intensity Application of eXciteOSA | Pittsburgh Sleep Quality Index (PSQI) | 5.5 score on a scale | Standard Deviation 2.7 |
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
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Quality of Life as Measured by EuroQol Score | 0.88 score on a scale | Standard Deviation 0.13 |
| High Intensity Application of eXciteOSA | Quality of Life as Measured by EuroQol Score | 0.84 score on a scale | Standard Deviation 0.08 |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Short Form-20 (SF-20) Scores | 76.6 score on a scale | Standard Deviation 28.5 |
| High Intensity Application of eXciteOSA | Short Form-20 (SF-20) Scores | 86.5 score on a scale | Standard Deviation 15 |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Snoring Visual Analog Scores | 50.3 score on a scale | Standard Deviation 22 |
| High Intensity Application of eXciteOSA | Snoring Visual Analog Scores | 42.5 score on a scale | Standard Deviation 27.4 |
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.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity Application of eXciteOSA | Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | 1.0 score on a scale | Standard Deviation 4.2 |
| High Intensity Application of eXciteOSA | Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | 9.5 score on a scale | Standard Deviation 17.2 |