Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea

Sponsor
Restera, Inc.
Study ID
NCT07303452
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurostimulation — DEVICE
    Neurostimulation via Restera Serene System

Study Details

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.

Key Dates

First listed
Dec 24, 2025
Start date
Dec 31, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
May 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Target
  • Experimental: Dual Target

Primary Outcome Measure

Safety of the Restera Serene System [ Time Frame: 6 months ]

Central Contacts

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