N/A
N=107
High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01971567 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Change From Baseline in Insomnia Severity Index (ISI) — -6.98; -4.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIRREM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insomnia Severity Index (ISI) |
-6.98; -4.94 | — |
| SECONDARY Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset |
-1.00; -0.56; -28.42; -22.64 | — |
| SECONDARY Change in Total Sleep Time (TST) |
1.15; 0.58 | — |
| SECONDARY Change in RestRefresh and SleepQual |
0.60; 0.54; 0.79; 0.67 | — |
| SECONDARY Change From Baseline in Beck Depression Inventory - II (BDI-II) |
-3.76; -2.65 | — |
| SECONDARY Change From Baseline in Beck Anxiety Inventory (BAI) |
-0.25; -0.25 | — |
| SECONDARY Change From Baseline in EQ-5D |
2.73; 0.11 | — |
| SECONDARY Change in Heart Rate Variability (HRV) |
57.28; 35.81; 53.06; 26.86 | — |
| SECONDARY Change in Baroflex Sensitivity (BRS) |
24.78; 16.26; 20.36; 12.31 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01971567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.