Back to resultsAdherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study) (AEGIS)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eXciteOSA
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years
- Ability to consent
- Home sleep apnea test demonstrating mild obstructive sleep apnea.
- Smartphone or tablet
Exclusion Criteria:
- Current pacemaker, defibrillator, or neuro-stimulation device
- No prior oropharyngeal surgery for sleep apnea
- No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
- No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
- Heart failure (New York Heart Association Class 3 or 4; or ejection fraction < 45%)
- Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
- Uncontrolled hypertension (BP > 160/100)
- Clinician diagnosis of any chronic lung disease except asthma
- Chronic fatigue syndrome or fibromyalgia
- Self-reported current illicit drug use in the past 30 days
- Self-reported use of marijuana or opiates in the past 30 days
- Use of supplemental oxygen
- Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
- Current pregnancy or intention of becoming pregnant
- Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
- Periodic breathing (Cheyne Stoke respiration)
- Central sleep apnea (central apnea index (CAI) > 5/h)
- Investigator discretion
- Prisoners
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low intensity application of eXciteOSA
High intensity application of eXciteOSA
Arm Description
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
Outcomes
Primary Outcome Measures
Mean Number of Days Device Was Used
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Secondary Outcome Measures
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.
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.
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.
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.
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
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.
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.
Number of Participants Accepting Long Term Treatment
Number of participants reporting acceptance of long term treatment will be reported
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974515
Brief Title
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
Acronym
AEGIS
Official Title
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low intensity application of eXciteOSA
Arm Type
Experimental
Arm Description
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
Arm Title
High intensity application of eXciteOSA
Arm Type
Active Comparator
Arm Description
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
eXciteOSA
Intervention Description
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
Primary Outcome Measure Information:
Title
Mean Number of Days Device Was Used
Description
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Mean Respiratory Event Index (REI)
Description
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
Title
Epworth Sleepiness Scale (ESS) Scores
Description
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
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Title
Short Form-20 (SF-20) Scores
Description
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
Title
Quality of Life as Measured by EuroQol Score
Description
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
Title
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Description
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
Title
Snoring Visual Analog Scores
Description
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
Title
Number of Participants Accepting Long Term Treatment
Description
Number of participants reporting acceptance of long term treatment will be reported
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years
Ability to consent
Home sleep apnea test demonstrating mild obstructive sleep apnea.
Smartphone or tablet
Exclusion Criteria:
Current pacemaker, defibrillator, or neuro-stimulation device
No prior oropharyngeal surgery for sleep apnea
No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
Heart failure (New York Heart Association Class 3 or 4; or ejection fraction < 45%)
Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
Uncontrolled hypertension (BP > 160/100)
Clinician diagnosis of any chronic lung disease except asthma
Chronic fatigue syndrome or fibromyalgia
Self-reported current illicit drug use in the past 30 days
Self-reported use of marijuana or opiates in the past 30 days
Use of supplemental oxygen
Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
Current pregnancy or intention of becoming pregnant
Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
Periodic breathing (Cheyne Stoke respiration)
Central sleep apnea (central apnea index (CAI) > 5/h)
Investigator discretion
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naresh Punjabi, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
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