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

NCT01971567 | Completed Results FDA Device

• 1 other identifier: IRB00024763
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Electroencephalic; Biofeedback; Neural oscillations; Auto calibration; Relaxation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Insomnia Severity Index (ISI)

  The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.

  Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention

Secondary Outcomes (8)

• Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset

  Baseline and 8-10 weeks after completion of intervention

• Change in Total Sleep Time (TST)

  Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention

• Change in RestRefresh and SleepQual

  Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention

• Change From Baseline in Beck Depression Inventory - II (BDI-II)

  Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention

• Change From Baseline in Beck Anxiety Inventory (BAI)

  Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention

Study Arms (2)

HIRREM

ACTIVE COMPARATOR

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.

Device: HIRREM

Placebo

PLACEBO COMPARATOR

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.

Device: HIRREM

Interventions

HIRREM DEVICE

Also known as: High-resolution, relational, resonance-based, electroencephalic mirroring, Brainwave Optimization

HIRREM; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• 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.

  PMID: 23532171 BACKGROUND

• 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.

  PMID: 23170244 BACKGROUND

• 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.

  PMID: 32940419 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Charles H. Tegeler
• Organization: Wake Forest School of Medicine

ctegeler@wakehealth.edu

+1 (336) 716-7651

Study Officials

• Charles H. Tegeler, MD

  Department of Neurology, Wake Forest School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: December 12, 2016
• Study Completion: February 6, 2017
• Last Updated: September 10, 2018
• Results First Posted: May 21, 2018

Record last verified: 2018-08

Locations

US (1)