Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
Recruiting
N/A
Interventional Study
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Restera, Inc. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Body Mass Index (BMI) ≤ 32 kg/m2
* AHI between 15-65 events/hour
* Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
Exclusion Criteria:
* Pregnancy or breast-feeding
* Significant upper airway anatomic abnormalities
* Signific…
Contacts