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Behavioural Intervention
Cereset Intervention for Stress and Anxiety (LT-HW Trial)
N/A
Recruiting
Led By Charles H 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to year 1
Awards & highlights
LT-HW Trial Summary
This trial studied the long-term benefits of a 4-session intervention for people with health issues, compared to usual care.
Who is the study for?
This trial is for healthcare workers over 18 who feel stressed (PSS score ≥ 14), can follow instructions, sit still for sessions, and commit to a year-long study. It's not for those without internet, severe hearing issues, over 400 pounds, using certain brain therapies recently or enrolled in another study.Check my eligibility
What is being tested?
The trial tests long-term effects of 'Cereset Research', an acoustic stimulation therapy after initial sessions versus usual care. Participants are randomly assigned to either continue with the therapy or receive standard care after their first four sessions.See study design
What are the potential side effects?
Since this intervention involves non-invasive acoustic stimulation, side effects may be minimal but could include discomfort from wearing earbuds or sitting still during sessions. Specific side effects aren't detailed but would likely relate to sensory experiences.
LT-HW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Perceived Stress Scale (PSS) scores
Secondary outcome measures
Change in Generalized Anxiety Disorder-7 (GAD-7) scores
Change in Insomnia Severity Index (ISI) scores
LT-HW Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cereset Research Control GroupExperimental Treatment1 Intervention
All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.
Group II: Cereset Research Tune-Up Intervention GroupActive Control1 Intervention
All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,640 Total Patients Enrolled
Susanne Marcus Collins Foundation, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Charles H Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
528 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known seizure disorder.I cannot sit comfortably for up to an hour or attend study visits.I am available and interested in joining a study for 1 year.I am an employed healthcare worker and I am 18 years or older.I am unable to give informed consent for the trial.I have used HIRREM, BWO, Cereset, or similar brainwave optimization technologies.I haven't had specific brain treatments like ECT or TMS in the last month.I weigh more than 400 pounds.I am experiencing high levels of stress.I can follow simple instructions and sit still comfortably.
Research Study Groups:
This trial has the following groups:- Group 1: Cereset Research Tune-Up Intervention Group
- Group 2: Cereset Research Control Group
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 seniors over 75 years old excluded from this investigation?
"This clinical trial is accessible to patients aged between 18 and 100. There are 115 trials for minors, while those above 65 have access to 380 such studies."
Answered by AI
Are there still openings within this research endeavor for volunteers?
"Per data hosted on clinicaltrials.gov, this medical trial is not actively recruiting at the present time. Initially posted in September of 2023 and last updated August 8th, there are 537 other trials that require patient participation currently."
Answered by AI
Am I eligible to join this clinical investigation?
"To participate in this medical trial, volunteers must be between 18 and 100 years of age with a primary diagnosis of anxiety. A maximum recruitment count of 90 people has been set for the duration of the experiment."
Answered by AI
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