Janus II Feasibility

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Zoll Medical Corporation
Study ID
NCT06556693
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dual Channel Stimulation — DEVICE
    implant of dual channel stimulation device

Study Details

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.

Key Dates

Start date
Aug 12, 2025
Status verified
Oct 2025
Primary completion
Apr 30, 2028
Completion
Dec 31, 2034

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group

Primary Outcome Measure

Safety through 12 months [ Time Frame: 12 Months post implant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The Insomnia and Sleep Institute of Arizona LLCScottsdaleArizona85255
Shelley Beaver, RC
[email protected]
480-745-3547
Sriharsha Vajjala, MD (PRINCIPAL_INVESTIGATOR)
The University of Michigan Health-WestWyomingMichigan49519
Stefanie Davis
[email protected]
Timothy Daum, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Kalyn Ferguson
[email protected]
Ralph Augostini, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
The Insomnia and Sleep Institute of Arizona LLC· Scottsdale, AZThe University of Michigan Health-West· Wyoming, MIThe Ohio State University· Columbus, OH

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