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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04974515
Recruitment Status : Completed
First Posted : July 23, 2021
Last Update Posted : December 30, 2022
Sponsor:
Information provided by (Responsible Party):
Naresh Punjabi, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: eXciteOSA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
Actual Study Start Date : August 17, 2021
Actual Primary Completion Date : October 31, 2022
Actual Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
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.
 Device: eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
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.
 Device: eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. Number of participants accepting long term treatment [ Time Frame: 6 weeks ]
    Number of participants reporting acceptance of long term treatment will be reported


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974515


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Naresh Punjabi, MD University of Miami
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Naresh Punjabi, Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT04974515    
Other Study ID Numbers: 20210068
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: December 30, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases