Recruiting

Remedē® System

Sponsor:

Zoll Medical Corporation

Code:

NCT06556693

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Dual Channel Stimulation

Study Details

Brief summary:

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.

Conditions

Sleep Apnea

Study ID

NCT06556693

Start date

Aug 12, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2034

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

Interventions

Dual Channel Stimulation

implant of dual channel stimulation device

Primary outcome measure

  • Safety through 12 months [ Time Frame: 12 Months post implant ]
  • Successful Implantation [ Time Frame: implant procedure ]
  • Improvement in sleep disordered breathing [ Time Frame: 12 months post implant ]

Central Contacts and Locations

Central contacts

Samuel Kolapo

205-441-9519samuel.kolapo@zoll.com

Kathy McPherson

615-613-6321kmcpherson@zoll.com

Locations

The Insomnia and Sleep Institute of Arizona LLC

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

Shelley Beaver, RC

480-745-3547research@sleeplessinarizona.com

Principal Investigator:

Sriharsha Vajjala, MD

The University of Michigan Health-West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Stefanie Davis

Stefanie.Davis@umhwest.org

Principal Investigator:

Timothy Daum, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kalyn Ferguson

Kalyn.Ferguson@osumc.edu

Principal Investigator:

Ralph Augostini, MD

More Information

Sponsor

Zoll Medical Corporation

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zoll Medical Corporation on 2025-10-29.