N/A
N=8
HIRREM Hot Flashes Study
Vasomotor Symptoms · Hot Flashes · Menopause
Bottom Line
View on ClinicalTrials.gov: NCT03512002 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Reduction in Hot Flash Severity Score Based on Diary Data — -0.39; -0.38 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIRREM (Device); Continued Current Care (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Hot Flash Severity Score Based on Diary Data |
-0.39; -0.38 | — |
| SECONDARY Change in Heart Rate Variability |
-0.20; -5.42 | — |
| SECONDARY Change in Baroreflex Sensitivity |
1.60; -1.54 | — |
| SECONDARY Change in Insomnia Severity Index (ISI) |
-11.33; -3.80 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
-2.67; -0.40 | — |
| SECONDARY Change in Epworth Sleepiness Score (ESS) |
-6.00; -0.40 | — |
| SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) |
-9.33; 2.80 | — |
| SECONDARY Change in Generalized Anxiety Disorder-7 (GAD-7) |
-2.67; 0.20 | — |
| SECONDARY Change in Perceived Stress Scale (PSS) |
-1.67; -0.20 | — |
| SECONDARY Change in Quality of Life Scale (QOLS) |
8.33; -1.40 | — |
| SECONDARY Change in Drop Stick Reaction Time |
3.88; 3.85 | — |
| SECONDARY Change in Grip Strength |
6.00; 3.20; 3.56; 2.00 | — |
| SECONDARY Change in Hot Flash Related Daily Interference Scale (HFRDIS) |
-34.67; -0.20 | — |
| SECONDARY Change in Menopause Rating Scale (MRS) |
-8.00; 0.00 | — |
Summary
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for women in any stage of menopause, who are experiencing menopause-related hot flashes.
Eligibility Criteria
Inclusion Criteria
- Women, age 40 and above
- Intact uterus and ovaries
- Have at least 5 hot flashes per day (with at least one being categorized as moderate to severe, in a stable pattern for one month).
Exclusion Criteria
- Less than 5 hot flashes per day
- Does not experience at least 1 moderate to severe hot flash per day
- Unable, unwilling, or incompetent to provide informed consent
- Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours
- Known seizure disorder
- Known or potential pregnancy (females with last menstrual period less than one year from enrollment will be tested for pregnancy prior to randomization)
- Severe hearing impairment (because the subject will be using headphones during the interventions)
- Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
- Use of pharmaceuticals for treatment of vasomotor symptoms or any type of hormone replacement therapy
- Use of supplements for improvement of vasomotor symptoms including but not limited to black cohosh, soy isoflavone extract, and red clover leaf extract
- Menopausal symptoms resulting from, or associated with surgery, chemotherapy, radiation, or use of other chemicals or medications
- Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
- Ongoing need for treatment with thyroid medications
- Weight is over the chair limit (285 pounds)
- Are enrolled in another research study that includes an active intervention
- Have previously received brainwave optimization (BWO), used a B2 or a B2v2 wearable device, or previously participated in a HIRREM research study
Data sourced from ClinicalTrials.gov (NCT03512002). 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.