Trial Outcomes & Findings for Cereset Research In Healthcare Workers During COVID-19 (NCT NCT04682197)
NCT ID: NCT04682197
Last Updated: 2024-09-19
Results Overview
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.
COMPLETED
NA
144 participants
Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
2024-09-19
Participant Flow
Participant milestones
| Measure |
Cereset Intervention
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
|
Waitlist Control
Participants will continue their current care.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cereset Research In Healthcare Workers During COVID-19
Baseline characteristics by cohort
| Measure |
Cereset Research - Early Intervention
n=72 Participants
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
Continued Current Care - Delayed Intervention
n=72 Participants
Participants will continue their current care.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other/Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
72 participants
n=7 Participants
|
144 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe 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.
Outcome measures
| Measure |
Cereset Research
n=67 Participants
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
Continued Current Care
n=67 Participants
Participants will continue their current care.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
|---|---|---|
|
Change in Perceived Stress Scale (PSS)
|
-7.8 score on a scale
Standard Error 0.6
|
-1.2 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe 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.
Outcome measures
| Measure |
Cereset Research
n=67 Participants
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
Continued Current Care
n=67 Participants
Participants will continue their current care.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
|---|---|---|
|
Change in Insomnia Severity Index (ISI)
|
-6.3 score on a scale
Standard Error 0.6
|
-0.5 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe 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.
Outcome measures
| Measure |
Cereset Research
n=67 Participants
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
Continued Current Care
n=67 Participants
Participants will continue their current care.
Cereset Research: The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
|
-5.6 score on a scale
Standard Error 0.5
|
-1.3 score on a scale
Standard Error 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, \& D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionFatigue Severity Scale (FSS) is a nine-item instrument to assess how fatigue interferes with daily activities. Items are scored on a 7-point scale ranging from 1=strongly disagree to 7=strongly agree. Total scores range from 9 to 63 and the higher the rating demonstrates greater fatigue severity .
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionThe Depression, Anxiety, and Stress Scale (DASS-21) is a self-report scale with 21 items(Le et al., 2019; D. Lee, 2019). These questions are divided into three subscales to depression, anxiety, and stress, respectively. The depression subscale scoring ranges from normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27, and extremely severe depression (28-42). The anxiety subscale scoring ranges from normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). The stress subscale ranges from normal (0-10), mild stress (11-18), moderate stress (19-26), sever stress (27-34), and extremely severe stress (35-42). This scale is routinely used in COVID-19 (Wang et al., 2020) and SARS literature(McAlonan et al., 2007).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionMeasures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the interventionContinuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Cereset Intervention
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cereset Intervention
n=67 participants at risk
For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.
|
Waitlist Control
n=67 participants at risk
Participants will continue their current care.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Upper Back Pain
|
1.5%
1/67 • Number of events 1 • 1-7 weeks after completion of intervention
|
0.00%
0/67 • 1-7 weeks after completion of intervention
|
|
Reproductive system and breast disorders
Ovarian Cyst pain
|
1.5%
1/67 • Number of events 1 • 1-7 weeks after completion of intervention
|
0.00%
0/67 • 1-7 weeks after completion of intervention
|
|
General disorders
Migraine
|
1.5%
1/67 • Number of events 1 • 1-7 weeks after completion of intervention
|
0.00%
0/67 • 1-7 weeks after completion of intervention
|
|
Gastrointestinal disorders
Celiac Related
|
0.00%
0/67 • 1-7 weeks after completion of intervention
|
1.5%
1/67 • Number of events 1 • 1-7 weeks after completion of intervention
|
|
Surgical and medical procedures
Planned elective surgery
|
0.00%
0/67 • 1-7 weeks after completion of intervention
|
3.0%
2/67 • Number of events 3 • 1-7 weeks after completion of intervention
|
Additional Information
Dr. Charles H. Tegeler
Atrium Wake Forest Baptist Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place