Trial record 1 of 1 for:    IRB00024763
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High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Charles Tegeler, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01971567
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Insomnia
Device: HIRREM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia: A Randomized, Placebo-Controlled Clinical Trial

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: 8-10 weeks after completion of the intervention ] [ Designated as safety issue: No ]
    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. The ISI will be collected at enrollment (pre-intervention), and at 1-7 days, 8-10 weeks, and 16-18 weeks after completion of the intervention. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.


Secondary Outcome Measures:
  • Daily sleep diary [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ] [ Designated as safety issue: No ]
    This ten item instrument will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects.


Other Outcome Measures:
  • Beck Depression Inventory - II (BDI-II) [ Time Frame: 8-10 weeks after completion of the intervention ] [ Designated as safety issue: No ]
    Depression will be measured by the Beck Depression Inventory-II (BDI-II) which will be collected at enrollment (pre-intervention), and at 1-7 days, 8-10 weeks, and 16-18 weeks after completion of the intervention. The BDI-II is a 21-item questionnaire with response values of 0-3 for each item, yielding scores ranging from 0-63.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 8-10 weeks after completion of the intervention ] [ Designated as safety issue: No ]
    Anxiety will be measured by the Beck Anxiety Inventory (BAI), which will be completed at the enrollment visit (pre-intervention), as well as 1-7 days, 8-10 weeks, and 16-18 weeks after completion of the intervention. The BAI is a 21-item questionnaire with response values from 0-3 for each item, yielding scores ranging from 0-63.

  • EQ-5D [ Time Frame: 8-10 weeks after completion of the intervention ] [ Designated as safety issue: No ]
    Health-related quality of life will be measured by the EQ-5D, which will be collected at the enrollment visit, as well as 1-7 days, 8-10, and 16-18 weeks after completion of the intervention. The EQ-5D consists of 5 items assessing an individual's current health status (values from 0-2), yielding scores ranging from 0-10. Overall health status is also assessed with values from 0-100.


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: HIRREM
Other Names:
  • High-resolution, relational, resonance-based, electroencephalic mirroring
  • Brainwave Optimization
Placebo Comparator: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971567

Contacts
Contact: Lilana Hines 336-716-9447 lhines@wakehealth.edu
Contact: Debbie Singleton 336-716-9482 dsinglet@wakehealth.edu

Locations
United States, North Carolina
Department of Neurology, Wake Forest School of Medicine Not yet recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Nancy Buchheimer    336-716-3961    nbuchhe@wakehealth.edu   
Principal Investigator: Charles H Tegeler, MD         
Sub-Investigator: Sandhya R Kumar, MD         
Sub-Investigator: Catherine L Tegeler, BS         
Sub-Investigator: Jared F Cook, MA         
Sub-Investigator: Nicholas M Pajewski, PhD         
Sub-Investigator: Hossam A Shaltout, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Charles H Tegeler, MD Department of Neurology, Wake Forest School of Medicine
  More Information

Publications:
Responsible Party: Charles Tegeler, Professor of Neurology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01971567     History of Changes
Other Study ID Numbers: IRB00024763
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Insomnia
Electroencephalic
Biofeedback
Neural oscillations
Auto calibration
Relaxation

ClinicalTrials.gov processed this record on September 18, 2014