Clinical trial NCT03512002: HIRREM Hot Flashes Study
Official title: High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Vasomotor Symptoms (Hot Flashes) in Perimenopausal and Postmenopausal Women: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasomotor Symptoms
Hot Flashes
Menopause
Keywords: Neurotechnology
Autonomic Dysregulation
Hyperarousal
Brain Electrical Activity
HIRREM
Acoustic Stimulation
Perimenopausal
Postmenopausal
Hot Flashes
Night Sweats
Vasomotor Symptoms
Allostatis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 8
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies. The participants in the CCC group will be offered the opportunity to crossover and receive a course of HCC.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hot flashes. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.

This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.

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

Primary outcomes:
measure: Reduction in Hot Flash Severity Score Based on Diary Data
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
Secondary outcomes:
measure: Change in Heart Rate Variability
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Baroreflex Sensitivity
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Epworth Sleepiness Score (ESS)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Quality of Life Scale (QOLS)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Drop Stick Reaction Time
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Grip Strength
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
measure: Change in Menopause Rating Scale (MRS)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
Other outcomes:
measure: Change in Alcohol Intake Screening (Audit-C)
timeFrame: Baseline to V2 (4-6 weeks following completion of the intervention).
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H. Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References: