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

Wake Forest University (WFU)

Status: Completed

Conditions: Insomnia

Treatments: Device: HIRREM

Study type: Interventional

Funder types: Other

Identifiers

NCT01971567

IRB00024763

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 2 patient groups, including a placebo group

HIRREM

Active Comparator group

Description:

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.

Treatment:

Device: HIRREM

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: HIRREM