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Completed

NCT Number: NCT04974515

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eXciteOSA

Device

eXciteOSA is a device for improving genioglossus endurance through electrical stimulation

Primary outcomes

  1. Mean Number of Days Device Was Used

    Time frame: Up to 6 weeks

    Adherence level will be reported as the mean number of days the eXciteOSA device was used.

Secondary outcomes

  1. Mean Respiratory Event Index (REI)

    Time frame: Up to 6 weeks

    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.

  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. Quality of Life as Measured by EuroQol Score

    Time frame: Up to 6 weeks

    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

  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 0-100 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea

Acronym: AEGIS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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