Clinical trial NCT01971567: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia
Official title: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia: A Randomized, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Electroencephalic
Biofeedback
Neural oscillations
Auto calibration
Relaxation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Insomnia Severity Index (ISI)
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
Secondary outcomes:
measure: Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset
timeFrame: Baseline and 8-10 weeks after completion of intervention
measure: Change in Total Sleep Time (TST)
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change in RestRefresh and SleepQual
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change From Baseline in Beck Depression Inventory - II (BDI-II)
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change From Baseline in Beck Anxiety Inventory (BAI)
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change From Baseline in EQ-5D
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change in Heart Rate Variability (HRV)
timeFrame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
measure: Change in Baroflex Sensitivity (BRS)
timeFrame: 8-10 weeks after completion of the intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Department of Neurology, Wake Forest School of Medicine
name: Charles H. Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
citation: Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.
citation: Tegeler CL, Shaltout HA, Lee SW, Simpson SL, Gerdes L, Tegeler CH. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo-controlled clinical trial. Brain Behav. 2020 Nov;10(11):e01826. doi: 10.1002/brb3.1826. Epub 2020 Sep 17.