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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04298658
Eligibility Criteria:
Inclusion Criteria:
HIV with Insomnia
* Confirmed HIV diagnosis
* currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
* must be currently receiving stable antiretroviral therapy (ART).
* Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
HIV Without Insomnia
* Confirmed HIV diagnosis
* currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
* must be currently receiving stable antiretroviral therapy (ART).
* Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
Non HIV with Insomnia
* Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
* Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
Non HIV Without Insomnia
* Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
* Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
Exclusion Criteria:
* concurrent medical conditions that could confound
* interpretation of sleep
* pain
* inflammatory issues or coexisting diseases
* Systemic rheumatic disease/condition
* uncontrolled hypertension (i.e., BP \> 150/95)
* circulatory disorders (e.g., Reynaud's disease)
* history of heart disease or cardiac events
* history of cancer
* asthma AND use of an inhaler
* history of seizures
* history of stroke or other neurological disorder
* pregnancy
* core body temperature \> 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)
* unwilling to provide blood for this study
* non-English speaking
* recent injury or surgical procedure within past 6 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04298658
Study Brief:
Protocol Section:
NCT04298658