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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT05409651
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-70 years old
2. POTS, as defined by the presence of any of the following criteria:
* For patients age 20 or older, increase in heart rate ≥ 30 bpm within ten minutes of upright posture (tilt test or standing) from a supine position (For patients age 18-19, heart rate increase must be \>40 bpm)
* Associated with related symptoms that are worse with upright posture and that improve with recumbency
* Chronic symptoms that have lasted for longer than six months
* In the absence of other disorders, medications, or functional states that are known to predispose to orthostatic tachycardia
3. Baseline eating period \> 12-hour window
Exclusion Criteria:
4. Taking insulin within the last 6 months.
5. Manifest diabetes, defined as HbA1c \> 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
6. Known inflammatory and/or rheumatologic disease.
7. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
8. Pregnant or breast-feeding women.
9. Shift workers with variable (e.g. nocturnal) hours.
10. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
11. Planned travel to a time zone with greater than a 3-hour difference during study period.
12. History of a major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
13. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
14. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
15. History of adrenal disease.
16. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
17. Known history of type I diabetes.
18. History of eating disorder.
19. History of cirrhosis.
20. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
21. History of HIV/AIDS.
22. Currently enrolled in a weight-loss or weight-management program.
23. On a special or prescribed diet for other reasons (e.g. Celiac disease).
24. Currently taking any medication that is meant for, or has known effect on, appetite.
25. Any history of surgical intervention for weight management.
26. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
27. A score of \>16 on the Epworth Sleepiness Scale (ESS).
28. Depression determined by the Beck Depression Inventory (BDI-II) (unless previously diagnosed and well-controlled)
29. Failure to use the smartphone app for documentation (defined as \<2 meals/day for ≥3 days during baseline).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05409651
Study Brief:
Protocol Section:
NCT05409651