Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT05062057
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 40-62 years
2. Upper limit of 62 years because this is 10 years past the median age at menopause, which is the age range when most women experience menopause symptoms
3. Peri-menopausal women
* Defined as no menses in the past 3 months or menses in the past 3 months but cycles are less regular (as self-reported by the women)20
4. Postmenopausal women
* No menses for 12 months or longer
5. Women with surgical menopause will be included
6. Willing to wear the adhesive heart monitor on their chest for 28 days
7. Palpitations group: women who have reported palpitations within the previous 2 weeks
8. Control group: Women who report having no palpitations within the past 6 months
9. Completion of 2-week symptom diary
Exclusion Criteria:
1. Pregnant
2. Breastfeeding
3. History of arrhythmias (with the exception of sinus bradycardia, sinus arrhythmia or sinus tachycardia)
4. History of stroke
5. History of heart failure
6. Permanent pacemaker
7. Taking antiarrhythmic drugs (with the exception of ß-blockers, diltiazem or verapamil)
8. Known skin allergies (CAM patches are contraindicated)
9. Family history of skin allergies (CAM patches are contraindicated)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
62 Years
Study:
NCT05062057
Study Brief:
Protocol Section:
NCT05062057