Trials / Completed
CompletedNCT05252156
eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Signifier Medical Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. Up to 120 participants will be enrolled, in order to randomized n=62.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | eXciteOSA | eXciteOSA |
Timeline
- Start date
- 2022-03-21
- Primary completion
- 2022-10-26
- Completion
- 2022-10-31
- First posted
- 2022-02-23
- Last updated
- 2022-12-02
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05252156. Inclusion in this directory is not an endorsement.