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Cereset for Caregivers

NCT03935269 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-20

No results posted yet for this study

Summary

In this single arm, open label study, investigators will evaluate the feasibility of using the Cereset (formerly known as HIRREM - high-resolution relational, resonance-based electroencephalic mirroring) intervention for a stressed population confronting an acute burden on their lives - caregivers of newly diagnosed high-grade glioma patients. The Cereset intervention is a closed-loop acoustic stimulation intervention that has been studied in patients with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.

Conditions

Interventions

DEVICE

Cereset Research Wearable

CRW is a stress-relaxation device where participants listen to sounds that help to balance brain rhythms. Participants will be asked to come to an office for 5 days over 1-2 weeks, on your their schedule. Sessions will take approximately one (1) hour to complete.

PROCEDURE

Stress management therapy

Undergo Cereset research office intervention

OTHER

Questionnaire administration

Ancillary studies

OTHER

Quality of Life Assessment

Ancillary studies

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Roy Strowd, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935269 on ClinicalTrials.gov