N/A N=38 Treatment

Reducing the Experience of Menopausal Symptoms Through Temperature

Hot Flashes · Menopause

Bottom Line

View on ClinicalTrials.gov: NCT03937466 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Hot Flash Diary — 9 number of hot flashes per week

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cooling mattress pad (Device)
Age: Adult · 45+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Hot Flash Diary	4.5	—
PRIMARY Hot Flash Diary	4.5	—
PRIMARY Hot Flash Severity Index Score	7.8	—
PRIMARY Hot Flash Severity Index Score	7.8	—
SECONDARY Pittsburgh Sleep Quality Index (PSQI)	7.87	—
SECONDARY Pittsburgh Sleep Quality Index (PSQI)	7.87	—

Summary

The purposes of this study are to obtain preliminary evidence on the efficacy of a cooling mattress pad in reducing subjective hot flashes for peri and postmenopausal women experiencing menopausal hot flashes, and to obtain preliminary evidence on the efficacy of a cooling mattress pad for improving sleep for peri and postmenopausal women experiencing menopausal hot flashes.

Eligibility Criteria

Inclusion Criteria

Women aged 45-60
Peri or postmenopausal women (No periods for at least 3 months)
Experiencing at least 4 hot flashes per day on average per week

Exclusion Criteria

Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks.
Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
Initiated antidepressants in the last 3 months.
Changed their dose of an antidepressant in the last 3 months.
Women who describe their health as fair or poor.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03937466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.