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Completed

NCT Number: NCT05015803

Enhanced CBTi for Older Adult Sleep and Cognition

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).

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Key information

Conditions

Insomnia Alzheimers Disease Related Dementias Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

CBTi with Application

Combination Product

Participants randomized to this study arm will experience an attempted enhancement of standard video conferencing CBTi, that is facilitated with electronic device-based data and resources to the clinician. Noninvasive ambulatory worn and nearable devices deliver feedback of data to the clinician on an application interface. This information will be used to inform the therapeutic approach and to facilitate a living-space environment that is conducive to effective therapy.

Other names: Cognitive-Behavioral Therapy for Insomnia - Enhanced

CBTI

Behavioral

Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.

Other names: Cognitive-Behavioral Therapy for Insomnia - Standard

Sleep Hygiene Education

Behavioral

Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: 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.

Secondary outcomes

  1. Change in Sleep Maintenance Efficiency

    Time frame: Nightly (each night throughout study weeks 1-8)

    Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Sleep Maintenance Efficiency will be calculated (i.e. percentage of time between sleep onset and awakening for the main sleep period that is spent in the sleep state). Minimum score: 0% (i.e. no sleep); Maximum score: 100% (i.e. no awake time during the sleep window). Higher percentage score indicates that a greater proportion of the rest interval was spent actually asleep; increase in percentage score suggests improvement in sleep quality.

  2. Change in Total Sleep Time

    Time frame: Nightly (each night throughout study weeks 1-8)

    Objective ambulatory activity (actigraphy) and other biometric data will be collectively used to determine sleep state. From sleep state data, Total Sleep Time will be calculated (i.e. total minutes of nocturnal sleep). An increase in sleep time indicates improvement in sleep quantity.

  3. Change in Self-Reported Sleep

    Time frame: Daily (each morning throughout study weeks 1-8)

    Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, etc).

Other outcomes

  1. Change in cognitive test battery performance

    Time frame: Daily: Baseline (throughout 1st-2nd study weeks) and Post-Treatment (throughout 8th study week)

    Objective test performance metrics on an ambulatory cognitive test battery delivered with a smartphone device.

  2. Adherence to clinical therapeutic prescription

    Time frame: Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week)

    Attendance and completion of clinically assigned behavioral tasks (subjective patient self-report and evidence from objective data from ambulatory and nearable IoT devices).

  3. Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation

    Time frame: Baseline (week 2) vs. Post-Treatment (8th week)

    Blood biomarkers suggestive of Alzheimer's disease and related dementias (ADRD), including beta-amyloid (Aβ), Tau, Neurofilament Light chain protein, glial fibrillary acidic protein (GFAP), and brain-derived neurotrophic factor (BDNF). Blood biomarkers indicative of inflammation, including tumor necrosis factor-alpha (TNFα) and Interleukin inflammatory cytokines.

  4. Change in C-reactive Protein (CRP; mg/L)

    Time frame: Baseline (week 2) vs. Post-Treatment (8th week)

    C-reactive Protein (CRP), a blood biomarker indicative of inflammation.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Proactive Life Inc
  • University of Arizona

Registry information

Official study title

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

Acronym: R44

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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