Sleep Apnea, ObstructiveELMONCT05252156
eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
A study testing eXciteOSA in people with Sleep Apnea, Obstructive, run by Signifier Medical Technologies at 7 sites in United States.
Trial summary
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- eXciteOSA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Mar 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged >=18 years;
- Diagnosed with moderate OSA;
- Smartphone or tablet capable of running the eXciteOSA app;
- Fluent in written and spoken English.
Who cannot join
- BMI >=35 kg/m2;
- Implanted medical device;
- Dental braces and/or intraoral metal jewelry;
- Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
- Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
- Tonsillar hypertrophy (tonsil size grade 3 or greater);
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- Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;
- Prior oropharyngeal surgery for sleep-disordered breathing;
- At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;
- Use of any overnight therapy that cannot be withdrawn during study enrollment;
- Diagnosed with any sleep disorder other than OSA;
- Chronic use of central nervous system depressants;
- Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);
- Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;
- Considered by the PI to be at risk of an AE resulting from hypersomnolence;
- Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;
- Current or planned pregnancy;
- Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;
- Clinically-significant burden of comorbidities (including history of myocardial infarction, cardiac arrhythmia, heart failure, history of stroke, or transient ischemic attack), and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);
- Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21286
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Delta Waves
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
Clayton Sleep Institute
St Louis, Missouri, 63143
About this study
Official title: An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
- Conditions
- Sleep Apnea, Obstructive
- 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
| Study group | Role | What they receive |
|---|---|---|
| Therapy Dose-A | Experimental | Neuromuscular electrical stimulation; two 20-minute sessions per day. Receives: Device: eXciteOSA |
| Therapy Dose-B | Experimental | Neuromuscular electrical stimulation; one 30-minute session per day. Receives: Device: eXciteOSA |
| No Therapy | No intervention | Under the care of the referring physician, with no therapy applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start21 Mar 2022
- Primary completion26 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signifier Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasser Zayni, Study director, yasser.z@signifiermedical.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252156
- Sponsor's protocol ID
- SMT_EOSA_SZT_0003
- Acronym
- ELMO
- Status last verified
- Dec 2022
- First submitted
- 12 Feb 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial
- ClinicalTrials.gov ID
- NCT05252156
- Acronym / sponsor ID
- ELMO / SMT_EOSA_SZT_0003
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Signifier Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapy Dose-A | Experimental | Device: eXciteOSANeuromuscular electrical stimulation; two 20-minute sessions per day. |
| Therapy Dose-B | Experimental | Device: eXciteOSANeuromuscular electrical stimulation; one 30-minute session per day. |
| No Therapy | No intervention | –Under the care of the referring physician, with no therapy applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >=18 years;
- Diagnosed with moderate OSA;
- Smartphone or tablet capable of running the eXciteOSA app;
- Fluent in written and spoken English.
Key exclusion criteria (20 listed)
- BMI >=35 kg/m2;
- Implanted medical device;
- Dental braces and/or intraoral metal jewelry;
- Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
- Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
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 | Device | Therapy Dose-A, Therapy Dose-B |
Primary outcome
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- 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.
Yasser Zayni study director
yasser.z@signifiermedical.com
7 sites 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 Sleep Apnea, Obstructive, run by Signifier Medical Technologies at 7 sites 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 20 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy (time frame: Six 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 2 Dec 2022.