Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study) (AEGIS)

• ClinicalTrials.gov Identifier: NCT04974515
• Recruitment Status: Completed
• First Posted: July 23, 2021
• Last Update Posted: December 30, 2022
• Sponsor: University of Miami
• Information provided by (Responsible Party): Naresh Punjabi, University of Miami

Tracking Information

• First Submitted Date: July 13, 2021
• First Posted Date: July 23, 2021
• Last Update Posted Date: December 30, 2022
• Actual Study Start Date: August 17, 2021
• Actual Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2021)

Number of days device was used [ Time Frame: Up to 6 weeks ]

Adherence level will be reported as the number of days the eXcite OSA device was used

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 13, 2021)

• Respiratory event index [ Time Frame: Up to 6 weeks ]
  Respiratory event index (events/hr) will be evaluated using a home sleep apnea test. A higher REI indicates greater frequency of abnormal breathing during sleep.
• Epworth Sleepiness Scale (ESS) Scores [ Time Frame: 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) [ Time Frame: Up to 6 weeks ]
  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 [ Time Frame: 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.
• EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) Scores [ Time Frame: Up to 6 weeks ]
  Self-reported EQ-5D-5L 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 [ Time Frame: 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 [ Time Frame: Up to 6 weeks ]
  Partner reported Snoring visual analog has a total score ranging from 0-10 with the higher score indicating greater degree of snoring.
• Number of participants accepting long term treatment [ Time Frame: 6 weeks ]
  Number of participants reporting acceptance of long term treatment will be reported

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
• Official Title: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Obstructive Sleep Apnea

Intervention

Device: eXciteOSA

eXciteOSA is a device for improving genioglossus endurance through electrical stimulation

Study Arms

• Experimental: 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.
  Intervention: Device: eXciteOSA
• Active Comparator: 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.
  Intervention: Device: eXciteOSA

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2021): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 31, 2022
• Actual Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04974515
• Other Study ID Numbers: 20210068
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Naresh Punjabi, University of Miami
• Original Responsible Party: Alexandre Abreu, University of Miami, Associate Professor
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Naresh Punjabi, MD; University of Miami

• PRS Account: University of Miami
• Verification Date: December 2022