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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04932135
Eligibility Criteria:
Inclusion Criteria:
All participants:
* BMI 17 to 35 kg/m2
* Diagnosis of Graves' disease (matching one of the following criteria: elevated TRAb and/or ultrasonography and functional imaging consistent with Graves' disease)
* In possession of a smart phone
* Able to use a wearable device and willing to regularly upload their biometric data
* Informed consent as documented by signature (Appendix Informed Consent Form)
Group "treatment":
* TSH \< 0.2 mIU/l and
* fT4 \> 25 pM or fT3 \> 8 pM
* ATD planned, additional treatment with propranolol allowed
Group "surveillance":
* TSH within the reference range between 0.3 and 4.5 mlU/l
* Cessation of ATD is planned within the next 2-4 weeks
Exclusion Criteria:
* Chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol)
* Treatment with amiodarone
* Pacemaker with continuous stimulation.
* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* Abuse of alcohol or illicit drugs
* Allergic to nickel or silicone
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04932135
Study Brief:
Protocol Section:
NCT04932135