High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-02-06

Brief Summary

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The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, compared to placebo plus usual care.

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Normal Physiology

RECRUITING

Detailed Description

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Insomnia is the most prevalent sleep disorder and is associated with significant psychosocial and somatic pathology. Effective noninvasive interventions for insomnia are lacking. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), is a noninvasive, brain feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time. An open label, randomized, crossover pilot trial showed that HIRREM was safe and effective, with significant benefits for individuals with moderate to severe insomnia, based on differential change with symptoms of insomnia (Insomnia Severity Index, ISI). This study will extend those results in a larger cohort using a single blind, placebo controlled study design.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

HIRREM

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

HIRREM

Intervention Type DEVICE

Interventions

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HIRREM

Intervention Type DEVICE

Other Intervention Names

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High-resolution, relational, resonance-based, electroencephalic mirroring Brainwave Optimization

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe clinical insomnia (Insomnia Severity Index score of 15 or higher)

Exclusion Criteria

* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits
* Known obstructive sleep apnea
* Diagnosed periodic limb movement disorder or known restless legs syndrome
* Known seizure disorder
* Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
* Severe hearing impairment
* Known, or suspected diagnosis of post-traumatic stress disorder (PTSD)
* Known, relevant traumatic brain injury (TBI)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclics, and sleep medications such as zolpidem or eszopiclone
* Anticipated and ongoing use of recreational drugs or alcohol
* Lack of internet or smart phone access

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No