Study Summary
This trial will test whether Cereset can help improve stress, anxiety, and insomnia symptoms by improving autonomic function.
Eligible Conditions
- Psychophysiologic Disorders
- Neurological Disorders
- Neonatal Cardiovascular Conditions
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
Week 6
Change in Baroreflex Sensitivity
Change in Blood Pressure
Change in Blood Pressure Variability
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
Change in Heart Rate Variability
Change in Insomnia Severity Index (ISI)
Change in International Physical Activity Questionnaire (IPAQ-SF)
Change in PTSD Checklist for Civilians (PCL-C)
Change in Perceived Stress Scale (PSS)
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in Quality of Life Scale (QOLS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Experimental: Active CR
1 of 1
Experimental Treatment
150 Total Participants · 1 Treatment Group
Primary Treatment: Active CR · No Placebo Group · N/A
Experimental: Active CR
Device
Experimental Group · 1 Intervention: Active CR · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,149 Previous Clinical Trials
1,140,886 Total Patients Enrolled
The Susanne Marcus Collins Foundation, IncUNKNOWN
1 Previous Clinical Trials
138 Total Patients Enrolled
Charles Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
68 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been experiencing stress, anxiety, or trouble sleeping, and have scored above a certain level on self-reported questionnaires for each of these issues.
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Frequently Asked Questions
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." - Anonymous Online Contributor
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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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer