Study of the Effects of HIRREM-SOP for Insomnia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Pilot Trial of HIRREM-SOP for Insomnia

Conditions
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Insomnia, Sleep Deprivation

Intervention / Treatment
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* Device: HIRREM-SOP
* Device: NCC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Insomnia (Insomnia Severity Index ≥ 8) persisting by self-report for at least a month Subjects must have the ability to comply with basic instructions and be able to comfortably sit still with the sensor leads attached Exclusion Criteria: Unable, unwilling, or incompetent to provide informed consent Physically unable to come to the study visits, or to sit in a chair for several hours Known seizure disorder Known obstructive sleep apnea Diagnosed periodic limb movement disorder or known restless legs syndrome Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance Severe hearing impairment (because the subject will be using ear buds during HIRREM-SOP) Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks Weight is over the chair limit (285 pounds) Currently in another active intervention research study Previous history of receiving or using HIRREM, BWO, HIRREM-SOP, or the wearable B2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will compare acoustic stimulation linked to brainwave activity (HIRREM-SOP, along with continued current care, BCC) with acoustic stimulation not linked to brainwave activity (NCC, along with continued current care). The participants in the NCC group with will offered the opportunity to crossover and receive a course of BCC at the end of their original participation.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIRREM-SOP (BCC<br>Acoustic stimulation linked to brainwave activity and continued current care. | Device: HIRREM-SOP<br>* 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.<br>|
| Other: nonspecific acoustic stimulation (NCC)<br>Continued current care and acoustic stimulation that is not linked to brainwave activity. | Device: HIRREM-SOP<br>* 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.<br>Device: NCC<br>* Nonspecific acoustic stimulation with randomly generated tones not linked to brain activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, before Session 5, V2 (0-14 days after intervention completion), V3 (4-6 weeks following V2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurotechnology, Autonomic Dysregulation, Hyperarousal, Brain Electrical Activity, Closed-loop, Acoustic Stimulation, Allostasis, Insomnia, HIRREM-SOP, Sleep Deprivation