Obstructive Sleep Apnea
Conditions
Brief summary
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.
Interventions
DEVICENeurostimulation
Neurostimulation via Restera Serene System
Sponsors
Restera, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Significant positionally-dependent OSA * Participants taking medications that may alter body weight
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Restera Serene System | 6 months | Incidence of device and/or procedure-related serious adverse events |
| Effectiveness of the Restera Serene System | 6 months | Change from baseline in the Apnea-Hypopnea Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Safety of the Restera Serene System | 36 months | Incidence of device and/or procedure-related serious adverse events |
| Long-term Effectiveness of the Restera Serene System | 36 months | Change from baseline in the Apnea-Hypopnea Index |
Countries
Australia
Contacts
Primary ContactTim Fayram
Outcome results
None listed