Mobile app to reduce hot flashes and improve sleep
A Mobile App for Hot Flashes and Sleep Disturbances (Evia): Randomized Controlled Trial
This study is testing two mobile apps to see if they can help post-menopausal women reduce hot flashes and improve their sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Baylor University Academic / other |
| Locations | 1 site (Waco, Texas) |
| Trial ID | NCT06718803 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and user acceptance of two mobile health applications designed to reduce hot flashes and related symptoms in post-menopausal women. Participants will engage with the Evia app, which delivers hypnotherapy sessions and educational content over a five-week period, while tracking their hot flashes and sleep quality. The study is conducted entirely remotely, allowing for greater accessibility and convenience for participants. The research is grounded in established evidence supporting hypnotherapy as a viable non-hormonal intervention for managing hot flashes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and older who experience a minimum of 36 hot flashes per week and can access the mobile app.
Not a fit: Patients who do not have access to a smartphone or who are currently using other treatments for hot flashes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive, easily accessible treatment option for managing hot flashes and improving sleep quality in menopausal women.
How similar studies have performed: While hypnotherapy has shown efficacy in treating hot flashes in face-to-face settings, this is the first randomized controlled trial evaluating a mobile app approach for this purpose.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Waco, Texas
- Baylor University — Waco, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Vanessa Muniz, MA
- Email: Vanessa_muniz1@baylor.edu
- Phone: (956)645-8109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.