Janus II Feasibility

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2034-12-31

Brief Summary

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The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.

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Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Dual Channel Stimulation

Intervention Type DEVICE

implant of dual channel stimulation device

Interventions

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Dual Channel Stimulation

implant of dual channel stimulation device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe sleep disordered breathing
* Expected to tolerate study procedures
* No heart failure or medically stable heart failure

Exclusion Criteria

* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
* History of severe COPD or pulmonary arterial hypertension
* Current or previous history of nerve injury or palsy
* Prior cervical surgeries or radiation treatment to head region
* Known need for an MRI
* History of psychosis or severe bipolar disorder
* Active Infection or sepsis within 30 days of enrollment
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No