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

Completed · Not applicable · Has a placebo group

Conditions studied: Insomnia

In brief

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.

Key facts

Study ID: NCT01971567
Run by: Wake Forest University Health Sciences
People needed: 107
Starts: 2013-10-01
Expected to finish: 2017-02-06
Last updated by the study team: 2018-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Department of Neurology, Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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