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NCT Number: NCT07303452

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Western Australia

Perth, Australia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurostimulation

Device

Neurostimulation via Restera Serene System

Primary outcomes

  1. Safety of the Restera Serene System

    Time frame: 6 months

    Incidence of device and/or procedure-related serious adverse events

  2. Effectiveness of the Restera Serene System

    Time frame: 6 months

    Change from baseline in the Apnea-Hypopnea Index

Secondary outcomes

  1. Long-term Safety of the Restera Serene System

    Time frame: 36 months

    Incidence of device and/or procedure-related serious adverse events

  2. Long-term Effectiveness of the Restera Serene System

    Time frame: 36 months

    Change from baseline in the Apnea-Hypopnea Index

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Restera, Inc.

Industry

Registry information

Official study title

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.

Acronym: REST-HGN+AC

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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