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Behavioural Intervention
Continued Current Care for Hot Flashes
N/A
Waitlist Available
Led By Charles H. Tegeler, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to v2 (4-6 weeks following completion of the intervention).
Awards & highlights
Study Summary
This trial will study whether a technique called HIRREM can help reduce hot flashes for menopausal women.
Eligible Conditions
- Hot Flashes
- Menopause
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to v2 (4-6 weeks following completion of the intervention).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to v2 (4-6 weeks following completion of the intervention).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in Hot Flash Severity Score Based on Diary Data
Secondary outcome measures
Change in Baroreflex Sensitivity
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Change in Drop Stick Reaction Time
+10 moreOther outcome measures
Change in Alcohol Intake Screening (Audit-C)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Continued Current CareExperimental Treatment2 Interventions
Participants will continue their current care.
Group II: HIRREMActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HIRREM
2018
N/A
~460
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,229 Total Patients Enrolled
4 Trials studying Hot Flashes
467 Patients Enrolled for Hot Flashes
Charles H. Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
107 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities to participate in this clinical experiment?
"The clinicaltrials.gov entry for this trial confirms that it is no longer actively recruiting patients, with the last update being on October 26th 2022. Although not enrolling any new participants at present, there are 58 other trials currently welcoming volunteers."
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