Evaluation of the Restera™ Serene™ System in Adults With... | NCT07303452

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

NCT07303452

Sponsor

Restera, Inc.

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Neurostimulation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official 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.

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

May 2029Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Dec 10, 2025

First Posted Date

Dec 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Target	Experimental		Device: Neurostimulation
Dual Target	Experimental		Device: Neurostimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurostimulation	Device	Neurostimulation via Restera Serene System	Dual Target Single Target

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tim Fayram	Contact	408-612-7570		tfayram@resterasleep.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Western Australia	Recruiting	Perth			Australia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided