Obstructive Sleep ApneaAEGISNCT04974515
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
A study testing eXciteOSA in people with Obstructive Sleep Apnea, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- eXciteOSA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Ability to consent
- Home sleep apnea test demonstrating mild obstructive sleep apnea.
- Smartphone or tablet
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- eXciteOSA
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eXciteOSADevice
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Low intensity application of eXciteOSA | Experimental | Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. Receives: Device: eXciteOSA |
| High intensity application of eXciteOSA | Active comparator | Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. Receives: Device: eXciteOSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Days Device Was Used
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Measured: Up to 6 weeks
Secondary outcomes (8)
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.
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
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
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
Number of Participants Accepting Long Term Treatment
Number of participants reporting acceptance of long term treatment will be reported
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start17 Aug 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naresh Punjabi, University of Miami
- Investigators
- Naresh Punjabi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974515
- Sponsor's protocol ID
- 20210068
- Acronym
- AEGIS
- Status last verified
- Oct 2023
- First submitted
- 13 Jul 2021
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
- ClinicalTrials.gov ID
- NCT04974515
- Acronym / sponsor ID
- AEGIS / 20210068
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 16 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity application of eXciteOSA | Experimental | Device: eXciteOSAParticipants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. |
| High intensity application of eXciteOSA | Active comparator | Device: eXciteOSAParticipants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Ability to consent
- Home sleep apnea test demonstrating mild obstructive sleep apnea.
- Smartphone or tablet
Key exclusion criteria (19 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eXciteOSAeXciteOSA is a device for improving genioglossus endurance through electrical stimulation | Device | High intensity application of eXciteOSA, Low intensity application of eXciteOSA |
Primary outcome
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.
8 secondary outcomes
Mean Respiratory Event Index (REI)
Time frame: Up to 6 weeks
Epworth Sleepiness Scale (ESS) Scores
Time frame: Up to 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 6 weeks
Short Form-20 (SF-20) Scores
Time frame: Up to 6 weeks
Quality of Life as Measured by EuroQol Score
Time frame: Up to 6 weeks
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Time frame: Up to 6 weeks
Snoring Visual Analog Scores
Time frame: Up to 6 weeks
Number of Participants Accepting Long Term Treatment
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naresh Punjabi, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eXciteOSA in people with Obstructive Sleep Apnea, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Days Device Was Used (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.