Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT03935269
Status:
WITHDRAWN
Last Update Posted:
2024-03-20
First Post:
2019-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cereset for Caregivers
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Can We Relieve the Stress: Cereset for Caregivers
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No accruals, DSMB/PRC closed study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CERESET
Brief 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.
Detailed Description:
Primary Objective:
• To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.
Secondary Objectives
* To assess the tolerability of the intervention
* To assess changes in trial participant wellbeing and quality of life.
* To assess changes in physiological response at pre-intervention and post-intervention time points.
Exploratory Objectives
* To assess the utilization of Cereset Research Wearable (portable, limited scope wearable device) after the CRO intervention.
* To assess the participant acceptability of the Cereset Research Intervention.
• To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.
Secondary Objectives
* To assess the tolerability of the intervention
* To assess changes in trial participant wellbeing and quality of life.
* To assess changes in physiological response at pre-intervention and post-intervention time points.
Exploratory Objectives
* To assess the utilization of Cereset Research Wearable (portable, limited scope wearable device) after the CRO intervention.
* To assess the participant acceptability of the Cereset Research Intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: