HIRREM Hot Flashes Study

NCT ID: NCT03512002

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-05-27

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.

Conditions

Vasomotor Symptoms; Hot Flashes; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HIRREM

High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.

Group Type: ACTIVE_COMPARATOR

HIRREM

Intervention Type: DEVICE

Technology

Continued Current Care

Intervention Type: OTHER

Continue their current clinical care.

Continued Current Care

Participants will continue their current care.

Group Type: OTHER

HIRREM

Intervention Type: DEVICE

Technology

Continued Current Care

Intervention Type: OTHER

Continue their current clinical care.

Interventions

HIRREM

Technology

Intervention Type: DEVICE

Continued Current Care

Continue their current clinical care.

Intervention Type: OTHER

Other Intervention Names

High-resolution, relational, resonance-based, electroencephalic mirroring; Brainwave Optimization

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles H. Tegeler, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00049252

Identifier Type: -

Identifier Source: org_study_id