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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
University of Miami
Miami, Florida, United States
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
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
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
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
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
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
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.
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Time frame: 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.
Time frame: Up to 6 weeks
Number of Participants Accepting Long Term Treatment
Number of participants reporting acceptance of long term treatment will be reported
Time frame: 6 weeks