eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea

(ELMO Trial)

Recruiting at 6 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

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the eXciteOSA device on patients with moderate obstructive sleep apnea (OSA). The device sends gentle electrical pulses to the tongue muscles to help keep the airway open during sleep. The study will compare the effects of using the device at two different doses over a period of time. The eXciteOSA device, developed by Signifier Medical Technologies Ltd., is used for daytime neuromuscular electrical training of tongue muscles to improve snoring and mild obstructive sleep apnea.

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.

Research Team

Yasser Zayni

Principal Investigator

[e-mail]

Eligibility Criteria

Inclusion Criteria

Fluent in written and spoken English.

Diagnosed with moderate OSA;

Smartphone or tablet capable of running the eXciteOSA app;

Timeline

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

Treatment Details

Interventions

• eXciteOSA

Participant Groups

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+