Trials / Unknown
UnknownNCT05183009
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
An Open-label Randomized Controlled Trial Assessing the Efficacy of Intraoral Neuromuscular Electrical Stimulation for Treatment of Mild Obstructive Sleep Apnea: The OREM Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (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 mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | eXciteOSA | eXciteOSA |
Timeline
- Start date
- 2022-01-17
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-01-10
- Last updated
- 2022-12-02
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05183009. Inclusion in this directory is not an endorsement.