Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea (REST-HGN+AC)

Restera, Inc.

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Neurostimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07303452

IM-010

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Single Target

Experimental group

Treatment:

Device: Neurostimulation

Dual Target

Experimental group

Treatment:

Device: Neurostimulation