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

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ClinicalTrials.gov Identifier: NCT01971567
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Insomnia Device: HIRREM Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia: A Randomized, Placebo-Controlled Clinical Trial
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : February 6, 2017

Arm Intervention/treatment
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.
Device: HIRREM
Other Names:
  • High-resolution, relational, resonance-based, electroencephalic mirroring
  • Brainwave Optimization




Primary Outcome Measures :
  1. Change From Baseline in Insomnia Severity Index (ISI) [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset [ Time Frame: Baseline and 8-10 weeks after completion of intervention ]
    This 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. Measurements of sleep onset latency (SOL) and wake after sleep onset (WASO) were recorded in minutes.

  2. Change in Total Sleep Time (TST) [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    This 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. Participants recorded the total sleep time (TST) they had each night. The outcome indicates the average increase (in hours) of the amount of sleep that each group reported.

  3. Change in RestRefresh and SleepQual [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    This 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. Participants were asked to report a self-rating on how well they felt rested and refreshed (RestRefresh) and to rate the quality of sleep they had (SleepQual). Both questions were rated on a 0 to 4 scale and higher scores denotes better outcomes for each.

  4. Change From Baseline in Beck Depression Inventory - II (BDI-II) [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    Depression will be measured by the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item questionnaire with response values of 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.

  5. Change From Baseline in Beck Anxiety Inventory (BAI) [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    Anxiety will be measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item questionnaire with response values from 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.

  6. Change From Baseline in EQ-5D [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    Health-related quality of life will be measured by the EQ-5D. The EQ-5D consists of 5 items assessing an individual's current health status (values from 0-2), yielding scores ranging from 0-10. Higher scores denotes worse outcomes.

  7. Change in Heart Rate Variability (HRV) [ Time Frame: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds)and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.

  8. Change in Baroflex Sensitivity (BRS) [ Time Frame: 8-10 weeks after completion of the intervention ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system at 1000 Hz, are analyzed using Nevrokard BRS software. Analysis is conducted on the first complete 5-minute epoch. Power spectral densities of systolic blood pressure (SBP) and R-R interval (RRI) oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (HF: 0.15-0.4 Hz). The square-root of the ratio of RRI's and SBP powers is computed to calculate HF alpha indices, which reflect BRS. The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is then calculated for Sequence UP, DOWN and TOTAL (seq ALL).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971567


Locations
United States, North Carolina
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Charles H. Tegeler, MD Department of Neurology, Wake Forest School of Medicine

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01971567     History of Changes
Other Study ID Numbers: IRB00024763
First Posted: October 29, 2013    Key Record Dates
Results First Posted: May 21, 2018
Last Update Posted: May 21, 2018
Last Verified: May 2018

Keywords provided by Wake Forest University Health Sciences:
Insomnia
Electroencephalic
Biofeedback
Neural oscillations
Auto calibration
Relaxation

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders