Enhanced CBTi for Older Adult Sleep and Cognition

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Insomnia, Alzheimers Disease Related Dementias

Intervention / Treatment
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* Combination Product: CBTi with Application
* Behavioral: CBTi
* Behavioral: Sleep Hygiene Education


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBTi with Application<br>Device-based intervention facilitation and clinician interfacing for Cognitive Behavioral Therapy for Insomnia (CBTi). | Combination Product: CBTi with Application<br>* 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.<br>* Other names: Cognitive-Behavioral Therapy for Insomnia - Enhanced;|
| Active Comparator: CBTi<br>Standard CBTi delivered via video conferencing [Zoom Health]. | Behavioral: CBTi<br>* Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.<br>* Other names: Cognitive-Behavioral Therapy for Insomnia - Standard;|
| Active Comparator: Sleep Hygiene<br>Treatment as usual: Sleep hygiene education and training. | Behavioral: Sleep Hygiene Education<br>* Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | 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. | Weekly (each of study weeks 1-8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Maintenance Efficiency | 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. | Nightly (each night throughout study weeks 1-8) | 
| Change in Total Sleep Time | 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. | Nightly (each night throughout study weeks 1-8) | 
| Change in Self-Reported Sleep | Subjective sleep diary data will be used to determine perceived sleep features (duration, quality, etc). | Daily (each morning throughout study weeks 1-8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral therapy (CBT), sleep, ADRD, insomnia