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临床试验/NCT05015803
NCT05015803已完成2 期

A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk

Penn State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月16日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in Insomnia Severity Index

研究概览

简要总结

This randomized clinical trial on 60+ aged and independent-living healthy individuals with symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).

详细描述

Telehealth-delivered enhanced CBTi (integrated with a sleep diary app, a therapist dashboard, and data from IoT devices) will be compared to standard telehealth CBTi and to usual treatment with sleep hygiene education. The investigators will determine effects on insomnia (primary outcome) and on clinical sleep metrics (secondary outcome), among other outcomes including cognitive performance, blood biomarkers of ADRD, and therapeutic adherence.

After screening consent and qualification, informed consent, and adherence evaluation with ambulatory devices (1wk), study participants are pseudo-randomized into one of 3 study arms (2:2:1, Enhanced CBTi : Standard CBTi : Sleep Hygiene). The living space of participants is equipped with IoT data collection devices. Participants take surveys related to sleep, have blood drawn, wear ambulatory devices, complete cognitive evaluations, and interact with nearable living space devices and an iPhone interface during a preparation week leading up to an intake telehealth appointment. Baseline data collection (1wk) occurs. Participants then adhere to behavioral therapy directives prescribed at weekly telehealth sessions with a clinically qualified therapist, take surveys related to sleep, complete cognitive evaluations, wear ambulatory devices, and interact with nearable living space devices and an iPhone interface throughout the study intervention period of 6 weeks. During the final week (coinciding with the 6th intervention week), participants have a second blood draw and return all study equipment/devices at the conclusion of participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This is a single-blind study design. The therapeutic care for insomnia is synonymous with the study intervention, therefore blinding of the CBT care provider is impossible.

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent English speaker/reader
  • Resident of the state/commonwealth of Pennsylvania for tax purposes
  • Ability to complete (sign) own consent form
  • Age 60-90 (inclusive, at enrollment)
  • Independent Living status (or equivalent; if dwelling in a community living facility)
  • Insomnia Severity Index (ISI) screening survey score of >=11
  • Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
  • Willing to maintain existing physician-directed intervention for issues pertaining to sleep for the duration of study participation
  • Has a residence with access to WiFi

排除标准

  • Has a pacemaker
  • Illicit drug use in the past month
  • Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
  • Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
  • Cohabiting with a current or previous participant in this study
  • Evidence of Cognitive Impairment (a score of <18 on the abbreviated Montreal Cognitive Assessment [MoCA] screening evaluation)

结局指标

主要结局

Change in Insomnia Severity Index

时间窗: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)

Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.

次要结局

  • Change in Sleep Maintenance Efficiency(Nightly (each night throughout study weeks 1-8))
  • Change in Total Sleep Time(Nightly (each night throughout study weeks 1-8))
  • Change in Self-Reported Sleep(Daily (each morning throughout study weeks 1-8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Orfeu M. Buxton

Elizabeth Fenton Susman Professor of Biobehavioral Health

Penn State University

研究点 (2)

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