NCT02709369

HIRREM Developmental Study

Completed NA Results posted Last updated 24 December 2019

What this trial tests

NA trial testing HIRREM in Sleep Initiation and Maintenance Disorders in 300 participants. Completed in 25 October 2018.

Timeline

23 August 2011

Primary endpoint
25 October 2018

25 October 2018

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	23 August 2011
Primary completion	25 October 2018
Estimated completion	25 October 2018
Sites	1 location across United States

Drugs / interventions tested

• HIRREM

Conditions studied

• Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
• Anxiety — all drugs for Anxiety →
• Post-Traumatic Stress Disorder — all drugs for Post-Traumatic Stress Disorder →
• Hot Flashes — all drugs for Hot Flashes →

Sponsor

Wake Forest University Health Sciences

Who can join

11 and older, any sex, with Sleep Initiation and Maintenance Disorders or Anxiety. 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.

Heart Rate Variability Standard Deviation of NN Intervals (SDNN) Primary · Baseline/Enrollment visit

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

Group	Value	95% CI
Active HIRREM	44.41	± 22.94

Heart Rate Variability (SDNN) Primary · Up to 2 weeks after the intervention is completed

Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

Group	Value	95% CI
Active HIRREM	54.82	± 30.63

Baroreflex Sensitivity High Frequency (HF) Alpha Primary · Baseline/Enrollment visit

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	18.81	± 14.45

Baroreflex Sensitivity High Frequency (HF) Alpha Primary · Up to two weeks after the intervention is completed

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	26.68	± 20.69

Baroreflex Sensitivity Sequence Up Primary · Baseline/Enrollment visit

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	15.39	± 13.88

Baroreflex Sensitivity Sequence Up Primary · Up to two weeks after the intervention is completed

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	14.15	± 11.56

Baroreflex Sensitivity Sequence Down Primary · Baseline/Enrollment visit

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	14.15	± 11.56

Baroreflex Sensitivity Sequence Down Primary · Up to two weeks after the intervention is completed

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	20.73	± 16.76

Baroreflex Sensitivity Sequence All Primary · Baseline/Enrollment visit

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	14.63	± 11.80

Baroreflex Sensitivity Sequence All Primary · Up to 2 weeks after the intervention is completed

Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Group	Value	95% CI
Active HIRREM	20.74	± 16.30

Center for Epidemiologic Studies Depression Scale (CES-D) Secondary · enrollment visit/baseline

The 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 the presence of more symptomatology.

Group	Value	95% CI
Active HIRREM	18.12	± 12.16

Center for Epidemiologic Studies Depression Scale (CES-D) Secondary · 1-2 weeks after intervention is completed

The 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 the presence of more symptomatology.

Group	Value	95% CI
Active HIRREM	10.00	± 8.96

Sponsor's own description

The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress.
   Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, et al · · 2017 · cited 21× · PMID 28420362 · DOI 10.1186/s12888-017-1299-x
2. Improvements in Heart Rate Variability, Baroreflex Sensitivity, and Sleep After Use of Closed-Loop Allostatic Neurotechnology by a Heterogeneous Cohort.
   Shaltout HA, Lee SW, Tegeler CL, Hirsch JR, et al · · 2018 · cited 15× · PMID 29922641 · DOI 10.3389/fpubh.2018.00116
3. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms.
   Tegeler CH, Tegeler CL, Cook JF, Lee SW, et al · · 2016 · cited 14× · PMID 27747793 · DOI 10.1186/s40798-016-0063-y