Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT03937466
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.
Detailed Description:
Women will be recruited from the community through flyers. They will call into a study phone line at which time they will be screened for their initial eligibility using a telephone screener. Women who are eligible and willing to participate, will either come to the Research Center in Winston-Salem to be consented and complete baseline questionnaires or complete these by mail or email. After two weeks, women will mail back their diaries and continue to record their daily hot flashes until they are notified by study staff of their eligibility, within a week of receiving the diary. If they qualify, a cooling mattress pad will be provided by study staff to be used for the duration of the intervention phase for approximately 8 weeks. The study staff will determine the efficacy of the cooling mattress pad through comparing answers to subject questionnaires at baseline and follow up in addition to comparing the baseline diaries to the intervention diaries.
Study:
NCT03937466
Study Brief:
Protocol Section:
NCT03937466