An interventional study of HIRREM-SOP and NCC in Insomnia and Sleep Deprivation, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
Prior research studies have shown benefit for use of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), to reduce symptoms of moderate to severe insomnia. HIRREM uses scalp sensors to monitor brain electrical activity, and software algorithms translate selected brain frequencies into audible tones in real time. Those tones (acoustic stimulation) are reflected back to participants via ear buds in as little as four milliseconds, providing the brain an opportunity to self-adjust and balance its electrical pattern.
The purpose of this research study is to determine the effects of HIRREM-SOP, an updated version of this technology that is based on the HIRREM approach, but now includes new hardware and software, a standardized series of HIRREM protocols, and a fixed number of sessions. Adults over the age of 18 who have documented sleep trouble that place them in the category of subthreshold (mild), moderate, or severe clinical insomnia as defined by the Insomnia Severity Index, are eligible to participate in the study.
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones to support real-time self-optimization of brain activity. Prior research demonstrates that the use of HIRREM is associated with reduced symptoms of insomnia, and traumatic stress and anxiety, and improved autonomic cardiovascular regulation across heterogeneous cohorts. HIRREM has been safe and well tolerated in about 500 people across six IRB-approved studies. However, the current in-office HIRREM approach remains very operator dependent (extensive Technologist education and experience) and takes a sizeable time commitment from the participant (typically ten or more sessions of 90-120 minutes each). To reduce participant time required, and operator dependence, while increasing scalability, a new generation of hardware and software has been developed. While based on the same core technology and algorithms to mirror brainwaves with audible tones, this includes the use of faster, 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols, all done with eyes closed (HIRREM-SOP). Although only 2 sensors are active at a time, applying 4 sensors, for which the software can switch from one pair to the other automatically, cuts in half the number of sensor placement changes needed, with reduced session time and interruptions. A modified placebo condition now includes random timing and pitch of the tones, which have not been acoustically engineered. This pilot study will evaluate feasibility of this standardized, enhanced approach, and the effectiveness of blinding for the placebo condition in participants with symptoms of insomnia.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 22 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acoustic stimulation linked to brainwave activity and continued current care.
Device: HIRREM-SOP
Continued current care and acoustic stimulation that is not linked to brainwave activity.
Device: HIRREM-SOP · Device: NCC
HIRREM-SOP is an updated version of HIRREM. It is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.
Change in ISI Score From V1 to V3
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 indicate the strength of the insomnia severity.
Time frame: Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
Number of Participants That Believe They Are Receiving HIRREM-SOP
The participant will indicate which arm of the intervention they believe they are receiving. The effectiveness will be evaluated based on the expectation measure regarding group assignment prior to the 5th session.
Time frame: Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2)
| Milestone | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) |
|---|---|---|
| Started | 10 | 12 |
| Completed | 9 | 11 |
| Not completed | 1 | 1 |
| Withdrew: Discontinued intervention (started sessions and dropped out due to time commitment and schedule) | 1 | 1 |
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 indicate the strength of the insomnia severity.
| score on a scale | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) |
|---|---|---|
| Change in ISI Score From V1 to V3 | -7.27 ± 1.55 | -4.69 ± 1.40 |
The participant will indicate which arm of the intervention they believe they are receiving. The effectiveness will be evaluated based on the expectation measure regarding group assignment prior to the 5th session.
| Participants | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) |
|---|---|---|
| Guessed BCC Group (Before Session 5) | 7 | 5 |
| Guessed NCC Group (Before Session 5) | 3 | 6 |
Collected over 16-18 weeks after completion of the intervention.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIRREM-SOP (BCC) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Nonspecific Acoustic Stimulation (NCC) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) |
|---|---|---|
| OtherNervous system disorders | 1/10 | 0/12 |
| Age, Continuous(Years) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| Mean | 58.6 ± 7.96 | 54.67 ± 19.19 | 56.45 ± 14.97 |
| Sex: Female, Male(Participants) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 6 | 8 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| United States | 10 | 12 | 22 |
| Insomnia Severity Index (ISI)(units on a scale) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| Mean | 14.90 ± 4.65 | 18.00 ± 3.07 | 16.59 ± 4.09 |
| Duration with Sleep Trouble(years) | HIRREM-SOP (BCC) | Nonspecific Acoustic Stimulation (NCC) | Total |
|---|---|---|---|
| Mean | 8.98 ± 11.43 | 5.28 ± 3.89 | 6.96 ± 8.22 |
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Wake Forest University Health Sciences