eXciteOSA for Obstructive Sleep Apnea

(ELMO Trial)

No longer recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Signifier Medical Technologies

Must not be taking: CNS depressants

Disqualifiers: BMI >=35, Implanted device, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a device called eXciteOSA for individuals with moderate obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. The study compares two usage methods—either two 20-minute sessions or one 30-minute session each day—against no treatment over six weeks. Participants must have a diagnosis of moderate OSA and need a smartphone or tablet to use the device app. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance sleep apnea treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who use overnight therapies that can't be stopped during the study and those who chronically use central nervous system depressants. It's best to discuss your specific medications with the trial team.

What prior data suggests that the eXciteOSA device is safe for patients with moderate OSA?

Research has shown that the eXciteOSA device, which uses gentle electrical pulses to strengthen tongue muscles, is generally safe. Studies have found that people with mild obstructive sleep apnea (OSA) usually tolerate this device well. Participants in these studies used the device during the day and found it easy to continue the treatment.

The FDA has approved the device to help reduce snoring and treat mild sleep apnea, indicating it has passed strict safety checks. However, all treatments can have side effects, and individual experiences may vary. It is important to consult a healthcare provider about potential risks and benefits before starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about eXciteOSA because it offers a non-invasive approach to treating moderate obstructive sleep apnea, unlike traditional options like CPAP machines or surgical interventions. The treatment uses neuromuscular electrical stimulation, which involves applying mild electrical pulses to strengthen the muscles in the tongue and upper airway, potentially reducing airway blockage. This technique is novel because it targets the root cause of sleep apnea with daily short sessions, potentially leading to better compliance and fewer side effects compared to more cumbersome or invasive methods.

What evidence suggests that the eXciteOSA device is effective for moderate OSA?

Research has shown that the eXciteOSA device can improve sleep apnea symptoms by using gentle electrical stimulation to strengthen muscles. One study found that people using the device experienced a significant improvement in their sleep apnea severity. Specifically, their apnea-hypopnea index (AHI), which measures sleep apnea severity, decreased from 10.2 events per hour to 6.8 events per hour, indicating symptom improvement. Additionally, using this device during the day has reduced snoring, a common issue with sleep apnea. In this trial, participants will be assigned to different treatment arms, including Therapy Dose-A and Therapy Dose-B, to evaluate the effectiveness of eXciteOSA in individuals with moderate obstructive sleep apnea. ^{3 5 6 7 8}

Who Is on the Research Team?

Yasser Zayni

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

Inclusion Criteria

Fluent in written and spoken English.

Diagnosed with moderate OSA;

Smartphone or tablet capable of running the eXciteOSA app;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the eXciteOSA device therapy for six weeks, with two different dosing regimens

6 weeks

Regular in-person visits for device monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eXciteOSA

How Is the Trial Designed?

Group I: Therapy Dose-B Experimental Treatment 1 Intervention

Neuromuscular electrical stimulation; one 30-minute session per day.

Group II: Therapy Dose-A Experimental Treatment 1 Intervention

Neuromuscular electrical stimulation; two 20-minute sessions per day.

Group III: No Therapy Active Control 1 Intervention

Under the care of the referring physician, with no therapy applied

Who Is Running the Clinical Trial?

Signifier Medical Technologies

Lead Sponsor

Trials

4

Recruited

480+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10752290/

Neuromuscular electrical stimulation for obstructive sleep ... In this randomised controlled trial, patients with mild obstructive sleep apnoea (OSA) were noted to adhere to daytime neuromuscular electrical stimulation.

2. exciteosa.com exciteosa.com/new-published-study-explores-cost-effectiveness-of-nmes/

New Published Study Explores Cost-Effectiveness of ... The results of the exploratory analysis indicated that neuromuscular electrical stimulation may be a cost-effective treatment option for mild OSA compared to no ...

3. exciteosa.com exciteosa.com/signifier-medical-technologies-announces-publication-of-peer-reviewed-analysis-demonstrating-improvement-in-obstructive-sleep-apnea-severity-with-neuromuscular-electrical-stimulation/

Signifier Medical Technologies Announces Publication of ... Based on the data from the peer-reviewed analysis, the researchers observed a significant improvement in the apnea-hypopnea index (AHI) from 10.2 to 6.8 events/ ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05183009

eXciteOSA for Treatment of Mild Obstructive Sleep Apnea The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33925376/

Daytime Neuromuscular Electrical Therapy of Tongue ... Daytime NMES (eXciteOSA) is demonstrated to be effective at reducing objective and subjective snoring. It is associated with effective improvement in patient ...

6. exciteosa.com exciteosa.com/wp-content/uploads/2021/04/HCP-Q_A.pdf

Questions & Answers eXciteOSA is intended for the reduction of snoring and mild obstructive sleep apnea by strengthening tongue muscles via electrical muscle stimulation.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200018.pdf

Neuromuscular tongue muscle stimulator for the reduction of ... eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild obstructive ...

8. exciteosa.com exciteosa.com/wp-content/uploads/2021/08/eXciteOSA-Payer-Summary-Reference.pdf

eXciteOSA® Product Information It received FDA De Novo classification,. DEN200018, on February 5, 2021 and is listed as a neuromuscular tongue muscle stimulator for the reduction of snoring ...