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

NCT ID: NCT07303452

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2029-05-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Target

Group Type EXPERIMENTAL

Neurostimulation

Intervention Type DEVICE

Neurostimulation via Restera Serene System

Dual Target

Group Type EXPERIMENTAL

Neurostimulation

Intervention Type DEVICE

Neurostimulation via Restera Serene System

Interventions

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Neurostimulation

Neurostimulation via Restera Serene System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Restera, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Western Australia

Perth, , Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Tim Fayram

Role: CONTACT

Phone: 408-612-7570

Email: [email protected]

Other Identifiers

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IM-010

Identifier Type: -

Identifier Source: org_study_id