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Набор скоро начнётся NCT07272863

The Impact of Brief Behavioral Treatment for Insomnia Versus Brief Mindfulness Treatment on Cognition and Sleep Health in Adults (Age 50+) With HIV

Без фазы С лечением Insomnia Cognition Aging HIV

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BBTI, BMT.
Кому может быть актуально
Состояния в реестре: Insomnia, Cognition, Aging, HIV. Базовые параметры: 50 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

  • Поведенческое BBTI
    4-week intervention delivered via telephone (once a week for 30 minutes)
  • Поведенческое BMT
    4-week intervention delivered via telephone (once a week for 30 minutes)

Первичные конечные точки

  • Insomnia Severity Index [Срок оценки: From enrollment until 1-year post-intervention]
  • 7-day Sleep Actigraphy [Срок оценки: From enrollment until 1-year post-intervention]
  • Consensus Sleep Diaries [Срок оценки: From enrollment until 1-year post-intervention]
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Срок оценки: From enrollment until 1-year post-intervention]
  • Delis-Kaplan Executive Function System (D-KEFS) [Срок оценки: From enrollment until 1-year post-intervention]
  • Patient's Assessment of Own Functioning Inventory (PAOFI) [Срок оценки: From enrollment until 1-year post-intervention]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: From enrollment until 1-year post-intervention]
Вторичные конечные точки (2)
  • Amyloid beta (Aβ42/40) [Срок оценки: From enrollment until 1-year post-intervention]
  • P-tau [Срок оценки: From enrollment until 1-year post-intervention]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • The University of Alabama at Birmingham — Birmingham
  • The University of Alabama — Tuscaloosa

Публикации

  • Cody SL, Kusko DA, Gonzalez CE, Owens MA, Hobson JM, Gilstrap SR, Thomas SJ, Goodin BR. Improving Sleep in People with HIV and Chronic Pain: A Pilot Study of Brief Behavioral Treatment for Insomnia. Behav Sleep Med. 2024 Nov-Dec;22(6):949-959. doi: 10.1080/15402002.2024.2396820. Epub 2024 Sep 8. PMID 39244666

Идентификаторы

NCT: NCT07272863 · 25-07-8836 · R01AG092240

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗