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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00096902
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects are patients referred for neurocardiogenic syncope or presyncope, with or without postural tachycardia syndrome (POTS). Patients enter the trial after positive tilt table testing during the screening evaluation. Participation is offered to individuals 18 years old or older, independently of gender, race, advanced age, ethnicity, religion, or any other demographic or sociopolitical classifications.
EXCLUSION CRITERIA:
Minors younger than 18 years old are excluded. Advanced age is not an exclusion criterion.
Patients who have certain illnesses that would interfere or be contraindicated with the interventions or procedures in this study are excluded. These include significant coronary artery disease, psychosis, or psychotic depression.
A candidate is excluded if the subject is unwilling to experience hypnosis or to have hypnosis sessions recorded; holds religious or other beliefs that would prevent engagement in hypnosis; is not fluent in spoken English; or has physical or other disabilities that prevent adequate participation in hypnotic susceptibility testing.
Certain herbal medicines or dietary supplements are known or suspected to interfere with the experimental results, and such herbal medicines or dietary supplements must be discontinued before enrollment in the study. For many herbal medicines or dietary supplements, the mechanisms of action and therefore the possible effects on the experimental results are unknown. In cases where the subjects wish to continue their herbal medicines or dietary supplements while on study, and search of the available medical literature fails to identify effects that are known or expected to interfere with the experimental results, then the subjects may participate.
A candidate is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results. Patients who cannot discontinue medications in the following categories are excluded: certain anti-hypertensives including beta-blockers, anticoagulants, tricyclic antidepressants, barbiturates, and acetaminophen. Patients unable to discontinue nicotine, caffeine, or alcohol for 24 hours prior to tilt table testing are excluded. Patients with chronic alcohol intake are excluded. Patients are not to discontinue any medications before the patient or the patient's doctor discusses this with the Principal Investigator, Accountable Investigator, an Associate Investigator, or Research Nurse. If it is decided that discontinuing medications would be unsafe, then the patient is excluded.
Patients who pose technical difficulties regarding the testing procedures are excluded.
A candidate is excluded if, in the judgment of the Principal Investigator, Accountable Investigator, or Clinical Director, protocol participation would place the subject at substantially increased acute medical risk, or if the medical risk outweighs the potential scientific benefit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00096902
Study Brief:
Protocol Section:
NCT00096902