Cereset Research Exploratory Study

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03777267
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Conditions After Birth
  • Neurological Diseases or Conditions
  • Psychophysiologic Disorders

Eligibility Criteria

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

Interventions

  • Active CR — DEVICE
    The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.

Study Details

The purpose of this study is to evaluate the use of Cereset Research to improve autonomic function in participants with symptoms of stress, anxiety, or insomnia.

Key Dates

Start date
Apr 12, 2019
Status verified
Jul 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental: Active CR
    For this single arm, open label, exploratory trial this will be the intervention arm using active CR.

Primary Outcome Measure

Change in Heart Rate Variability [ Time Frame: Baseline, and V3 (4-6 weeks after V2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health Scienc\essWinston-SalemNorth Carolina27157
Kenzie Brown
[email protected]
336-716-9447
Charles Tegeler, MD (PRINCIPAL_INVESTIGATOR)

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Wake Forest University Health Scienc\ess· Winston-Salem, NC

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