HIRREM Hot Flashes Study (NCT03512002) | Clinical Trial Compass
CompletedNot Applicable
HIRREM Hot Flashes Study
United States8 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 med…
What they're measuring
1
Reduction in Hot Flash Severity Score Based on Diary Data
Timeframe: Baseline to V2 (4-6 weeks following completion of the intervention).