N/A
Completed N=22
Study of the Effects of HIRREM-SOP for Insomnia
Source: ClinicalTrials.gov NCT03607994 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Change in ISI Score From V1 to V3 — -7.27; -4.69 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ISI Score From V1 to V3 |
-7.27; -4.69 | — |
| SECONDARY Number of Participants That Believe They Are Receiving HIRREM-SOP |
7; 5; 3; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03607994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.