The Impact of BBTI on Cognition and Sleep Health in Older Adults With HIV

Trial tests insomnia treatments for older adults with HIV

NCT: NCT07272863 · Status: NOT YET RECRUITING · Phase: N/A · Sponsor: University of Alabama, Tuscaloosa · Started: 2026-01 · Est. Completion: 2030-09

Plain English Summary

The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV is a Not Applicable clinical trial sponsored by University of Alabama, Tuscaloosa studying Insomnia, Cognition, Aging, HIV. This study compares two different 4-week telephone-delivered programs: Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Treatment (BMT). It is for adults aged 50 and older who have HIV and are experiencing insomnia. Participants will receive one of the two treatments over the phone and attend in-person visits for sleep and cognitive tests. Alternatives include standard medical treatments for insomnia and HIV management, as well as other mindfulness or behavioral therapies. The trial aims to enroll 214 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 50 or older, have HIV, and have been on HIV medication for at least a year. You must also have a diagnosis of insomnia that has lasted for at least 3 months. You cannot join if you have a diagnosis of Alzheimer's disease or dementia, severe memory problems, a history of stroke, or certain other neurological or sleep disorders like sleep apnea or bipolar disorder. You also cannot join if you are currently receiving chemotherapy or radiation, have had a significant brain injury, or are unable to speak English. This trial is studying Insomnia, Cognition, Aging, HIV, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure improvements in sleep quality and cognitive function, meaning the study will determine if the treatments help participants sleep better and think more clearly. The specific primary outcome measures are: Insomnia Severity Index (From enrollment until 1-year post-intervention); 7-day Sleep Actigraphy (From enrollment until 1-year post-intervention); Consensus Sleep Diaries (From enrollment until 1-year post-intervention); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (From enrollment until 1-year post-intervention); Delis-Kaplan Executive Function System (D-KEFS) (From enrollment until 1-year post-intervention). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it addresses the common issues of sleep and cognitive problems in older adults with HIV, aiming to find effective, non-drug treatments to improve their quality of life. This research targets Insomnia, Cognition, Aging, HIV, where improved treatment options are needed.

Investor Insight

This trial signals a focus on underserved populations within the HIV community, exploring non-pharmacological interventions for common comorbidities, which could lead to new treatment guidelines and a

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you, especially considering your HIV status and any sleep or memory concerns. Participation involves weekly 30-minute phone calls for 4 weeks, followed by in-person visits for tests. You will also have blood drawn at these visits to check for certain markers related to Alzheimer's disease. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* unable to speak English
* 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
* currently undergoing radiation/chemotherapy
* reports a history of brain trauma with loss of consciousness greater than 30 minutes
* have a learning disability
* have a documented diagnosis of sleep apnea (in medical records)
* reports use of a continuous positive airway pressure machine
* 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
* have restless leg syndrome and/or have narcolepsy
* have a documented history of bipolar disorder or psychotic disorder
* not be receiving efavirenz as part of their current ART regimen

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07272863?

NCT07272863 is a Not Applicable INTERVENTIONAL study titled "The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV." It is currently not yet recruiting and is sponsored by University of Alabama, Tuscaloosa. The trial targets enrollment of 214 participants.

What conditions does NCT07272863 study?

This trial investigates treatments for Insomnia, Cognition, Aging, HIV. The primary condition under study is Insomnia.

What treatments are being tested in NCT07272863?

The interventions being studied include: BBTI (BEHAVIORAL), BMT (BEHAVIORAL). 4-week intervention delivered via telephone (once a week for 30 minutes)

What does Not Applicable mean for NCT07272863?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07272863?

This trial is currently "Not Yet Recruiting." It started on 2026-01. The estimated completion date is 2030-09.

Who is sponsoring NCT07272863?

NCT07272863 is sponsored by University of Alabama, Tuscaloosa. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07272863?

The trial aims to enroll 214 participants. The trial has not yet started recruiting.

How is NCT07272863 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07272863?

The primary outcome measures are: Insomnia Severity Index (From enrollment until 1-year post-intervention); 7-day Sleep Actigraphy (From enrollment until 1-year post-intervention); Consensus Sleep Diaries (From enrollment until 1-year post-intervention); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (From enrollment until 1-year post-intervention); Delis-Kaplan Executive Function System (D-KEFS) (From enrollment until 1-year post-intervention). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07272863 being conducted?

This trial is being conducted at 2 sites, including Birmingham, Alabama; Tuscaloosa, Alabama (United States).

Where can I find official information about NCT07272863?

The official record for NCT07272863 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07272863. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07272863 testing in simple terms?

This study compares two different 4-week telephone-delivered programs: Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Treatment (BMT). It is for adults aged 50 and older who have HIV and are experiencing insomnia.

Why is this trial significant?

This trial is important because it addresses the common issues of sleep and cognitive problems in older adults with HIV, aiming to find effective, non-drug treatments to improve their quality of life.

What are the potential risks of participating in NCT07272863?

Potential side effects are generally related to the behavioral interventions and could include temporary frustration or increased awareness of sleep difficulties. Blood draws may cause minor discomfort or bruising at the site. There are no known major risks associated with the BBTI or BMT interventions themselves. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07272863?

Ask your doctor if this trial is a good fit for you, especially considering your HIV status and any sleep or memory concerns. Participation involves weekly 30-minute phone calls for 4 weeks, followed by in-person visits for tests. You will also have blood drawn at these visits to check for certain markers related to Alzheimer's disease. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07272863 signal from an investment perspective?

This trial signals a focus on underserved populations within the HIV community, exploring non-pharmacological interventions for common comorbidities, which could lead to new treatment guidelines and a This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive one of the two treatments over the phone and attend in-person visits for sleep and cognitive tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.