HIRREM Hot Flashes Study

NCT03512002 | Completed Results FDA Device

• 1 other identifier: IRB00049252
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction in Hot Flash Severity Score Based on Diary Data

  Both groups maintained a hot flash diary for 7-14 days, after which the intervention will begin for the HCC group. Post-intervention data collections will include an intermediate post-intervention visit (V2, primary outcome, 4-6 weeks after intervention completion for HCC, and 10-12 weeks after V1 for CCC), and a final follow up visit (V3, 12-14 weeks following completion of the intervention for HCC, and 18-20 weeks after V1 for CCC). Both groups will maintain a hot flash diary for 1-2 weeks prior to the V2 and V3 visits. The primary outcome will be change in hot flashes score from V1 to V2. The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes. Scale ranges from 0 (no hot flashes) to an open ended upper number (no max since participant dependent). A higher number suggest worse hot flashes.

  Baseline to V2 (4-6 weeks following completion of the intervention).

Secondary Outcomes (13)

• Change in Heart Rate Variability

  Baseline to V2 (4-6 weeks following completion of the intervention).

• Change in Baroreflex Sensitivity

  Baseline to V2 (4-6 weeks following completion of the intervention).

• Change in Insomnia Severity Index (ISI)

  Baseline to V2 (4-6 weeks following completion of the intervention).

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline to V2 (4-6 weeks following completion of the intervention).

• Change in Epworth Sleepiness Score (ESS)

  Baseline to V2 (4-6 weeks following completion of the intervention).

Other Outcomes (1)

• Change in Alcohol Intake Screening (Audit-C)

  Baseline to V2 (4-6 weeks following completion of the intervention).

Study Arms (2)

HIRREM

ACTIVE COMPARATOR

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.

Device: HIRREM; Other: Continued Current Care

Continued Current Care

OTHER

Participants will continue their current care.

Device: HIRREM; Other: Continued Current Care

Interventions

HIRREM DEVICE

Technology

Also known as: High-resolution, relational, resonance-based, electroencephalic mirroring, Brainwave Optimization

Continued Current Care; HIRREM

Continued Current Care OTHER

Continue their current clinical care.

Continued Current Care; HIRREM

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Participants must have an intact uterus and ovaries due to the nature of the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hot Flashes; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Medication exclusions and required minimum number of hot flashes per day made it difficult to recruit. COVID hit and the office shut down.

Results Point of Contact

• Title: Charles Tegeler, MD
• Organization: Atrium Wake Forest Baptist Health School of Medicine

BBRP@wakehealth.edu

336-716-9447

Study Officials

• Charles H. Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 30, 2018
• Study Start: June 1, 2018
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: May 23, 2023
• Results First Posted: May 23, 2023

Record last verified: 2022-10

Locations

US (1)