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

December 10, 2025 updated by: Restera, Inc.

A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Perth, Australia
        • Recruiting
        • University of Western Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Target
Device: Neurostimulation
Neurostimulation via Restera Serene System
Experimental: Dual Target
Device: Neurostimulation
Neurostimulation via Restera Serene System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the Restera Serene System
Time Frame: 6 months
Incidence of device and/or procedure-related serious adverse events
6 months
Effectiveness of the Restera Serene System
Time Frame: 6 months
Change from baseline in the Apnea-Hypopnea Index
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Safety of the Restera Serene System
Time Frame: 36 months
Incidence of device and/or procedure-related serious adverse events
36 months
Long-term Effectiveness of the Restera Serene System
Time Frame: 36 months
Change from baseline in the Apnea-Hypopnea Index
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restera, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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