RECRUITING

Cereset Research Exploratory Study

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Conditions

Neurological Diseases or ConditionsCardiovascular Conditions After BirthPsychophysiologic DisordersStressNeurotechnologyAutonomic DysregulationHyperarousalBrain electrical activityAllostasisHIRREMCereset ResearchInsomniaAnxiety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cereset Research Exploratory Study

Quick Facts

Study Start:2019-04-12
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03777267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
  2. * Subjects experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.
  1. * Unable, unwilling, or incompetent to provide informed consent/assent.
  2. * Physically unable to come to the study visits, or to sit comfortably in a chair for up to 1.5 hours.
  3. * Severe hearing impairment (because the subject will be using ear buds during CR).
  4. * Anticipated and ongoing use of alcohol or recreational drugs.
  5. * Weight is over the chair limit (285 pounds).
  6. * Currently in another active intervention research study.
  7. * Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2).
  8. * Prior use of electroconvulsive therapy (ECT).
  9. * Prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
  10. * Known seizure disorder.

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
336-716-9447
wfhirrem@wakehealth.edu

Principal Investigator

Charles Tegeler, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, 27104
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Charles Tegeler, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-12
Study Completion Date2026-04

Study Record Updates

Study Start Date2019-04-12
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Stress
  • Neurotechnology
  • Autonomic Dysregulation
  • Hyperarousal
  • Brain electrical activity
  • Allostasis
  • HIRREM
  • Cereset Research
  • Insomnia
  • Anxiety

Additional Relevant MeSH Terms

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