NCT07272863Not yet recruiting
The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV
The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are: What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT? Participants will: * Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- May 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- University of Alabama, Tuscaloosa
- Diseases
- HIV, Alzheimer disease
- NCT number
- NCT07272863
What you commit to
- Study type: Interventional
- Planned participants: 214
- From May 2026 to the primary completion date, Sept 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently undergoing radiation/chemotherapy
- not be receiving efavirenz as part of their current ART regimen
Other illness
- have a reported or documented (in medical records) diagnosis of AD or dementia
- have severe neurocognitive impairment (\>7 errors on the Short Portable Mental Status Questionnaire, SPMSQ) during telephone screening
- have a history of a stroke
- reports a history of brain trauma with loss of consciousness greater than 30 minutes
- have restless leg syndrome and/or have narcolepsy
- have a documented history of bipolar disorder or psychotic disorder
Age
- have been identified as high risk for moderate to severe sleep apnea (Snoring, Tiredness, Observed sleep apnea, Pressure, BMI, Age, Neck circumference, and Gender, STOP BANG ≥ 5) during telephone screening
Other
- unable to speak English
- have a learning disability
- have a documented diagnosis of sleep apnea (in medical records)
- reports use of a continuous positive airway pressure machine
Who the study is looking for
- must be age 50 or older
- have a DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months (indicated on the Structured Clinical Interview for Sleep Disorders, SCISD) during telephone screening
- have a confirmed HIV diagnosis and a prescribed ART regimen for at least 12 months.
Age in the registry: 50 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| The University of Alabama Coordinator of this site? Confirm its status | Tuscaloosa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.