NCT07303452

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025May 2029

First Submitted

Initial submission to the registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 28, 2025

Last Update Submit

December 10, 2025

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Safety of the Restera Serene System

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

    6 months

  • Effectiveness of the Restera Serene System

    Change from baseline in the Apnea-Hypopnea Index

    6 months

Secondary Outcomes (2)

  • Long-term Safety of the Restera Serene System

    36 months

  • Long-term Effectiveness of the Restera Serene System

    36 months

Study Arms (2)

Single Target

EXPERIMENTAL
Device: Neurostimulation

Dual Target

EXPERIMENTAL
Device: Neurostimulation

Interventions

NeurostimulationDEVICE

Neurostimulation via Restera Serene System

Dual TargetSingle Target

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnancy or breast-feeding
  • Significant upper airway anatomic abnormalities
  • Significant positionally-dependent OSA
  • Participants taking medications that may alter body weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Australia

Perth, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Tim Fayram

CONTACT

408-612-7570tfayram@resterasleep.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 24, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

May 1, 2029

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations

AU(1)