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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.
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
Study Summary
This trial will test whether Cereset can help improve stress, anxiety, and insomnia symptoms by improving autonomic function.
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.Check my eligibility
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.See study design
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 belowSelect...
I have stress, anxiety, or insomnia with qualifying scores on specific health questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Baroreflex Sensitivity
Change in Blood Pressure
Change in Blood Pressure Variability
+1 moreSecondary outcome measures
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 moreTrial 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.
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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
1,242 Previous Clinical Trials
1,004,117 Total Patients Enrolled
Charles Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious difficulty hearing (because you will need to use ear buds during the clinical trial).I weigh more than 285 pounds.I have stress, anxiety, or insomnia with qualifying scores on specific health questionnaires.I have used HIRREM, Brainwave Optimization, Cereset, or similar devices.I cannot or do not want to give permission for treatment.I cannot attend study visits or sit in a chair for 1.5 hours.You are currently using or are expected to use alcohol or recreational drugs.I haven't used brain stimulation or feedback treatments in the last month.I have a known seizure disorder.I can follow simple instructions and sit still with sensor leads attached.I have undergone electroconvulsive therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Active CR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for patients to join this medical experiment?
"Clinicaltrials.gov reports that this medical trial has begun its search for participants, having been initially published on April 12th 2019 and recently refreshed October 26th 2022."
Answered by AI
What are the chief aims of this medical investigation?
"The aims of this trial, evaluated at the Baseline stage, V2 (14 days after final session), and V3 (4-6 weeks after V2) are to assess changes in blood pressure. Additional secondary objectives include evaluating alterations in perceived stress levels using the PSS (scores range from 0-40); insomnia severity with ISI scores ranging between 0-28; and gauging PTSD symptoms via PCL-C ratings which vary across 17 questions on a Likert scale resulting in scores within a spectrum of 17 to 85."
Answered by AI
What is the total capacity of participants that this clinical trial can accept?
"Affirmative. The statistics posted on clinicaltrials.gov divulge that this research is now recruiting participants, with an initial post date of April 12th 2019 and most recent update from October 26th 2022. A total of 150 patients are desired for the study at a single site location."
Answered by AI
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