Reducing the Experience of Menopausal Symptoms Through Temperature

NCT03937466 | Completed Results FDA Device

• 1 other identifier: IRB00057388
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hot Flashes; Menopause

Keywords

hot flashes; menopause; cooling mattress pad

Outcome Measures

Primary Outcomes (4)

• Hot Flash Diary

  Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

  baseline

• Hot Flash Diary

  Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

  Week 10

• Hot Flash Severity Index Score

  The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.

  baseline

• Hot Flash Severity Index Score

  The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.

  Week 10

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Week 10

Other Outcomes (10)

• Hot Flash Related Daily Interference Scale (HFRDIS)

  baseline

• Hot Flash Related Daily Interference Scale (HFRDIS)

  follow up at 11 weeks

• Center for Epidemiologic Studies Depression Scale (CESD-10)

  baseline

Study Arms (1)

Experimental Cooling Mattress Pad

EXPERIMENTAL

Subjects will use a cooling mattress pad nightly for approximately 8 weeks

Device: Cooling mattress pad

Interventions

Cooling mattress pad DEVICE

The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.

Experimental Cooling Mattress Pad

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nancy Avis, PhD
• Organization: Wake Forest University School of Medicine

navis@wakehealth.edu

336-716-6974

Study Officials

• Nancy E Avis, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 24 peri or postmenopausal women aged 45-60 experiencing at least 4 hot flashes/night sweats/day will use a cooling mattress pad nightly for approximately 8 weeks

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: July 30, 2019
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: June 29, 2022
• Results First Posted: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)