Trial Outcomes & Findings for High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia (NCT NCT01971567)
NCT ID: NCT01971567
Last Updated: 2018-09-10
Results Overview
The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.
COMPLETED
NA
107 participants
Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
2018-09-10
Participant Flow
Participant milestones
| Measure |
HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
51
|
|
Overall Study
COMPLETED
|
52
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia
Baseline characteristics by cohort
| Measure |
HIRREM
n=56 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=51 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Duration with Sleep Trouble
|
11.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
12.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionThe ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.
Outcome measures
| Measure |
HIRREM
n=56 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=51 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change From Baseline in Insomnia Severity Index (ISI)
|
-6.98 units on a scale
Standard Error 0.74
|
-4.94 units on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Baseline and 8-10 weeks after completion of interventionPopulation: Data was not able to be collected for all participants.
This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Measurements of sleep onset latency (SOL) and wake after sleep onset (WASO) were recorded in minutes.
Outcome measures
| Measure |
HIRREM
n=47 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=39 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset
SOL
|
-1.00 minutes
Standard Error 0.18
|
-0.56 minutes
Standard Error 0.14
|
|
Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset
WASO
|
-28.42 minutes
Standard Error 8.00
|
-22.64 minutes
Standard Error 4.73
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionPopulation: Data was not able to be collected for all participants.
This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants recorded the total sleep time (TST) they had each night. The outcome indicates the average increase (in hours) of the amount of sleep that each group reported.
Outcome measures
| Measure |
HIRREM
n=47 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=39 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change in Total Sleep Time (TST)
|
1.15 hours
Standard Error 0.23
|
0.58 hours
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionPopulation: Data was not able to be collected for all participants.
This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants were asked to report a self-rating on how well they felt rested and refreshed (RestRefresh) and to rate the quality of sleep they had (SleepQual). Both questions were rated on a 0 to 4 scale and higher scores denotes better outcomes for each.
Outcome measures
| Measure |
HIRREM
n=47 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=39 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change in RestRefresh and SleepQual
RestRefresh
|
0.60 units on a scale
Standard Error 0.16
|
0.54 units on a scale
Standard Error 0.12
|
|
Change in RestRefresh and SleepQual
SleepQual
|
0.79 units on a scale
Standard Error 0.16
|
0.67 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionDepression will be measured by the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item questionnaire with response values of 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
HIRREM
n=52 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=49 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory - II (BDI-II)
|
-3.76 units on a scale
Standard Error 0.59
|
-2.65 units on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionPopulation: Data not collected for one participant in the placebo group
Anxiety will be measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item questionnaire with response values from 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
HIRREM
n=52 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=48 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change From Baseline in Beck Anxiety Inventory (BAI)
|
-0.25 units on a scale
Standard Error 0.10
|
-0.25 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionHealth-related quality of life will be measured by the EQ-5D. The EQ-5D consists of 5 items assessing an individual's current health status (values from 0-2), yielding scores ranging from 0-10. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
HIRREM
n=52 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=49 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change From Baseline in EQ-5D
|
2.73 units on a scale
Standard Error 1.90
|
0.11 units on a scale
Standard Error 1.94
|
SECONDARY outcome
Timeframe: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the interventionPopulation: Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity
Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds)and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.
Outcome measures
| Measure |
HIRREM
n=52 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=47 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change in Heart Rate Variability (HRV)
rMSSD
|
53.06 ms
Standard Error 5.34
|
26.86 ms
Standard Error 2.24
|
|
Change in Heart Rate Variability (HRV)
SDNN
|
57.28 ms
Standard Error 1.34
|
35.81 ms
Standard Error 1.77
|
SECONDARY outcome
Timeframe: 8-10 weeks after completion of the interventionPopulation: Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity
Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system at 1000 Hz, are analyzed using Nevrokard BRS software. Analysis is conducted on the first complete 5-minute epoch. Power spectral densities of systolic blood pressure (SBP) and R-R interval (RRI) oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (HF: 0.15-0.4 Hz). The square-root of the ratio of RRI's and SBP powers is computed to calculate HF alpha indices, which reflect BRS. The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is then calculated for Sequence UP, DOWN and TOTAL (seq ALL).
Outcome measures
| Measure |
HIRREM
n=52 Participants
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=47 Participants
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
Change in Baroflex Sensitivity (BRS)
HF Alpha
|
24.78 ms/mm Hg
Standard Error 2.17
|
16.26 ms/mm Hg
Standard Error 1.73
|
|
Change in Baroflex Sensitivity (BRS)
Seq ALL
|
20.36 ms/mm Hg
Standard Error 2.03
|
12.31 ms/mm Hg
Standard Error 1.09
|
Adverse Events
HIRREM
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIRREM
n=56 participants at risk
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
HIRREM
|
Placebo
n=51 participants at risk
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
HIRREM
|
|---|---|---|
|
General disorders
Change in sleep
|
3.6%
2/56 • 16-18 weeks after completion of the intervention
|
3.9%
2/51 • 16-18 weeks after completion of the intervention
|
|
Social circumstances
Change in emotions or awareness of feelings
|
1.8%
1/56 • 16-18 weeks after completion of the intervention
|
3.9%
2/51 • 16-18 weeks after completion of the intervention
|
|
General disorders
Head fullness
|
5.4%
3/56 • 16-18 weeks after completion of the intervention
|
3.9%
2/51 • 16-18 weeks after completion of the intervention
|
|
Skin and subcutaneous tissue disorders
Skin irritation at scalp sensor site
|
0.00%
0/56 • 16-18 weeks after completion of the intervention
|
2.0%
1/51 • 16-18 weeks after completion of the intervention
|
Additional Information
Dr. Charles H. Tegeler
Wake Forest School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place