Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
Purpose
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
Condition
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 22 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Body mass index (BMI) limitations - Likely suffer from moderate to severe OSA based on history and physical - Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments - Willing and capable of providing informed consent
Exclusion Criteria
- Inadequately treated sleep disorders other than OSA - Significant co-morbidities that contraindicates surgery or general anesthesia
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Genio Therapy |
The Genio™ system is an implantable neurostimulation system comprised of one implanted device |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Nyxoah S.A.