CompletedNot Applicable

A Mobile App for Hot Flashes and Sleep Disturbances

United States90 participantsStarted 2025-01-10

Plain-language summary

The purpose of the study is to compare the possible efficacy and acceptability of two mobile health applications for the reduction of hot flashes and related symptoms.This study is completely remote, and participants will be be asked to engage with a mobile health application daily for five weeks and provide feedback and experience with the app.

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 40 years or older and able to consent to participate in the study. * Self-reported history of a minimum of 36 hot flashes per week at baseline. * Ability to access the app to which the participant is randomized to (the Evia app or the Talli Care app). * Ability to speak and understand English. Non-English speakers are not considered in this study because the Apps are currently only offered in English. Exclusion Criteria: * New or changes in the current use of any prescription or complementary and alternative medicine (CAM) treatments for hot flashes during the duration of the intervention. \[If the participant is already using any prescription or CAM, they will be asked to provide details of ingredients, dose and frequency. They will be permitted to participate in the study if they agree to no change for the duration of their participation in the study and otherwise meet inclusion criteria.\] * Does not have access to a Smartphone * Severe or unstable medical or psychiatric illness. * Current use of hypnosis for any condition.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hot Flash Daily Diaries

Timeframe: From enrollment to the end of treatment (week 6)

Trial details

NCT IDNCT06718803

SponsorBaylor University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-21

View on ClinicalTrials.gov More Hot Flashes trials