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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT07090668
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of sickle-cell anemia (HbSS)
* Normal outer ear anatomy and intact skin for taVNS placement
* Hospitalized for a pain crisis and experiencing pain as a result of SCD
* Patients must have had at least one prior hospitalization for a sickle cell pain crisis in the past
Exclusion Criteria:
* History of seizures
* History of uncontrolled psychiatric illness
* Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving
* Cardiomyopathy
* Diagnosis of Acute Chest Syndrome
* Unrepaired congenital anomalies affecting the cardiovascular or respiratory system
* Hemodynamically unstable patients
* Females who are pregnant or lactating. Subjects who refuse a pregnancy test.
* Women of childbearing potential, not using adequate contraception as per the investigator's judgment, or not willing to comply with contraception for the duration of the study
* Patients with a history of surgery within the last 3 months
* Patients who suffered from a stroke within the last 3 months
* Patient admitted with a fever or who develops a fever throughout their hospitalization
* Patients whose disease-modifying therapy (HU, chronic transfusions, etc.) and/or pain medications (gabapentin, pregabalin, etc.) have not yet reached a steady dose
* Patients who have had 3 or more hospitalizations for acute pain crises in a given year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT07090668
Study Brief:
Protocol Section:
NCT07090668