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Not Applicable

Active CR for Stress, Anxiety, and Insomnia

N/A
Recruiting
Led By Charles Tegeler, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
Weight is over the chair limit (285 pounds)
Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a treatment called Cereset Research that uses sounds reflecting brain activity to help people aged 11 or older who have stress, anxiety, or insomnia. The sounds aim to balance the brain and improve automatic body functions.

Who is the study for?
This trial is for individuals experiencing stress, anxiety, or insomnia with certain scores on related self-reported inventories. Participants must be able to follow instructions and sit still with sensor leads attached. Excluded are those over 285 pounds, severe hearing impairment, using alcohol/drugs, or have used similar brainwave technologies recently.
What is being tested?
The study tests Cereset Research (CR), a method aimed at improving autonomic function in people with stress-related symptoms. It involves sitting comfortably while connected to sensor leads that presumably help balance brain rhythms associated with stress and sleep issues.
What are the potential side effects?
Specific side effects of CR are not detailed but may include discomfort from sitting still during sessions or unexpected reactions to the sensory experience. Since it's non-invasive, serious side effects are unlikely compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stress, anxiety, or insomnia with qualifying scores on specific health questionnaires.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh more than 285 pounds.
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I have used HIRREM, Brainwave Optimization, Cereset, or similar devices.
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I cannot or do not want to give permission for treatment.
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I cannot attend study visits or sit in a chair for 1.5 hours.
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I have a known seizure disorder.
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I have undergone electroconvulsive therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Baroreflex Sensitivity
Change in Blood Pressure
Change in Blood Pressure Variability
+1 more
Secondary study objectives
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Change in Generalized Anxiety Disorder-7 (GAD-7)
Change in HIRREM Physical Activity Satisfaction Questions
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Active CRExperimental Treatment1 Intervention
For this single arm, open label, exploratory trial this will be the intervention arm using active CR.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for psychophysiologic disorders include neurofeedback therapy, mindfulness-based stress reduction (MBSR), and cognitive-behavioral therapy (CBT). Neurofeedback therapy, such as the one studied in the Cereset Research trial, involves training individuals to modulate their brainwave activity, which can enhance autonomic function and improve symptoms of stress, anxiety, and insomnia. MBSR focuses on increasing awareness and self-regulation through meditation practices, which can help manage pain and stress responses. CBT aims to change negative thought patterns and behaviors, thereby reducing symptoms of anxiety and depression. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, leading to better management of their symptoms and overall well-being.
A simple and a complex tic (Gilles de la Tourette's syndrome): their response to EEG sensorimotor rhythm biofeedback training.Meta-analysis of randomized controlled trials of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions.

Find a Location

Who is running the clinical trial?

The Susanne Marcus Collins Foundation, IncUNKNOWN
1 Previous Clinical Trials
144 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,389 Previous Clinical Trials
2,546,608 Total Patients Enrolled
Charles Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Cereset Research (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT03777267 — N/A
Psychophysiologic Disorders Research Study Groups: Experimental: Active CR
Psychophysiologic Disorders Clinical Trial 2023: Cereset Research Highlights & Side Effects. Trial Name: NCT03777267 — N/A
Cereset Research (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03777267 — N/A
~11 spots leftby Apr 2025