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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT05097651
Eligibility Criteria:
Inclusion Criteria:
* HIV+ and HIV- adults with complaints of sleep problems
* Ability to provide informed consent;
* Read, speak, and understand English or Spanish as a first language;
* Willingness to stop sedative/hypnotic medication use;
* Willingness to abstain from substance use;
* Willingness to prevent pregnancy.
Exclusion Criteria:
* Inability to provide informed consent;
* Medical conditions other than HIV disease that may confound study results or pose risk when participating in the study;
* Neurologic disorder that could compromise interpretation of study findings, such as seizure disorder, stroke, demyelinating diseases, or head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications; and other non-HIV neurological disorders;
* Severe psychiatric disorder that might make the person's participation in the study problematic or unsafe, including psychiatric disorder with psychotic features, severe depression, or suicidality;
* Current sedative/hypnotic use for a non-sleep related indication or abuse within the last 12 months;
* Use of marijuana, CBD, or other natural or synthetic cannabinoids in the last 30 days;
* Any moderate to severe substance use disorder (dependence) in the last 12 months;
* Any mild substance use disorder (abuse) in the last 30 days;
* Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial;
* Compromised liver or kidney function;
* Evidence of cardiovascular risk,
* Uncontrolled hypertension;
* Chronic pulmonary disease;
* Obstructive sleep apnea, narcolepsy, or other non-insomnia sleep diagnosis;
* Overnight-shift work.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05097651
Study Brief:
Protocol Section:
NCT05097651