NCT03935269

Cereset for Caregivers

Can We Relieve the Stress: Cereset for Caregivers

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2019-05-02
• Last updated: 2024-03-20

Regulatory

• FDA-regulated device study