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

Obstructive Sleep Apnea Clinical Trial

— AEGIS  

Official title:

Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974515
• Other study ID #: 20210068
• Status: Completed
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Days Device Was Used	Adherence level will be reported as the mean number of days the eXciteOSA device was used.	Up to 6 weeks
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.	Up to 6 weeks
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.	Up to 6 weeks
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.	Up to 6 weeks
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.	Up to 6 weeks
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	Up to 6 weeks
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.	Up to 6 weeks
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.	Up to 6 weeks
Secondary	Number of Participants Accepting Long Term Treatment	Number of participants reporting acceptance of long term treatment will be reported	6 weeks