Trial Outcomes & Findings for Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study) (NCT NCT04974515)
NCT ID: NCT04974515
Last Updated: 2023-10-16
Results Overview
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2023-10-16
Participant Flow
Patients with mild sleep apnea recruited from sleep clinic and general community
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
Baseline characteristics by cohort
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
50.5 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Body Mass Index
|
28.9 kg/m2
STANDARD_DEVIATION 4.5 • n=93 Participants
|
28.4 kg/m2
STANDARD_DEVIATION 5.2 • n=4 Participants
|
28.6 kg/m2
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Respiratory event index
|
12.0 events/hr
STANDARD_DEVIATION 3.8 • n=93 Participants
|
12.6 events/hr
STANDARD_DEVIATION 3.7 • n=4 Participants
|
12.3 events/hr
STANDARD_DEVIATION 3. • n=27 Participants
|
|
Epworth Sleepiness Scale
|
10.3 units on a scale
STANDARD_DEVIATION 5.3 • n=93 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 5.8 • n=4 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 5.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksAdherence level will be reported as the mean number of days the eXciteOSA device was used.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Mean Number of Days Device Was Used
|
38.0 Days
Standard Deviation 8.3
|
38.4 Days
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Up to 6 weeksThe 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.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Mean Respiratory Event Index (REI)
|
12.6 events/hr
Standard Deviation 1.2
|
9.6 events/hr
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Up to 6 weeksSelf-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Scores
|
9.4 score on a scale
Standard Deviation 5.4
|
6.9 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Up to 6 weeksSelf-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
7.2 score on a scale
Standard Deviation 4.3
|
5.5 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Up to 6 weeksSelf reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Short Form-20 (SF-20) Scores
|
76.6 score on a scale
Standard Deviation 28.5
|
86.5 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Up to 6 weeksSelf-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
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Quality of Life as Measured by EuroQol Score
|
0.88 score on a scale
Standard Deviation 0.13
|
0.84 score on a scale
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Up to 6 weeksSelf-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
|
1.0 score on a scale
Standard Deviation 4.2
|
9.5 score on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Up to 6 weeksPartner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring.
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Snoring Visual Analog Scores
|
50.3 score on a scale
Standard Deviation 22.0
|
42.5 score on a scale
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 6 weeksNumber of participants reporting acceptance of long term treatment will be reported
Outcome measures
| Measure |
Low Intensity Application of eXciteOSA
n=19 Participants
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
|
High Intensity Application of eXciteOSA
n=21 Participants
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
|
|---|---|---|
|
Number of Participants Accepting Long Term Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Low Intensity Application of eXciteOSA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Intensity Application of eXciteOSA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Naresh M. Punjabi, MD, PhD
University of Miami, Miller School of Medicine
Phone: 305-243-6388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place