Last reviewed · How we verify

NCT04682197

Cereset Research In Healthcare Workers During COVID-19

Completed NA Results posted Last updated 19 September 2024
What this trial tests

NA trial testing Cereset Research in Health Personnel in 144 participants. Completed in 10 October 2023.

Timeline
14 December 2021
Primary endpoint
23 August 2023
10 October 2023

Quick facts

Lead sponsorWake Forest University Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment144
Start date14 December 2021
Primary completion23 August 2023
Estimated completion10 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Health Personnel or Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Perceived Stress Scale (PSS) Primary · Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.

GroupValue95% CI
Cereset Research-7.8± 0.6
Continued Current Care-1.2± 0.6
Change in Insomnia Severity Index (ISI) Secondary · Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Higher scores suggest increased insomnia.

GroupValue95% CI
Cereset Intervention-6.3± 0.6
Waitlist Control-0.5± 0.6
Change in Generalized Anxiety Disorder-7 (GAD-7) Secondary · Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

The Generalized Anxiety Disorder-7 is a seven-item screening tool for anxiety, with answer ranging from 0-3, yielding total scores from 0-21. This is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.

GroupValue95% CI
Cereset Intervention-5.6± 0.5
Waitlist Control-1.3± 0.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 1-7 weeks after completion of intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cereset Intervention
Serious: 0/67 (0%)
Deaths: 0/67
Waitlist Control
Serious: 0/67 (0%)
Deaths: 0/67
Other adverse events (5 terms — click to expand)

ReactionSystemCereset InterventionWaitlist Control
Planned elective surgerySurgical and medical procedures
Upper Back PainMusculoskeletal and connective tissue disorders
Ovarian Cyst painReproductive system and breast disorders
MigraineGeneral disorders
Celiac RelatedGastrointestinal disorders

Data from ClinicalTrials.gov NCT04682197 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Randomized Controlled Trial of Acoustic Neuromodulation to Enhance Well-Being in Healthcare Workers.
    Tegeler CL, Munger Clary H, Shaltout HA, Russell GB, et al · · 2025 · PMID 41132821 · DOI 10.1177/27536130251388984

Verify or expand the search:

Other trials of Cereset Research

Trials testing the same drug.

Other recruiting trials for Health Personnel

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04682197.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing