Clinical trial NCT05015803: Enhanced CBTi for Older Adult Sleep and Cognition
Official title: A Non-pharmacological Multi-modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Insomnia
Alzheimers Disease Related Dementias
Keywords: cognitive-behavioral therapy (CBT)
sleep
ADRD
insomnia
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Proactive Life Inc
First posted: 2021-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CBTi with Application, Standard TeleHealth CBTi, and Sleep Hygiene Education study groups run in parallel after randomization.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Screening (at enrollment qualification) and Weekly (each of study weeks 1-8)
Secondary outcomes:
measure: Change in Sleep Maintenance Efficiency
timeFrame: Nightly (each night throughout study weeks 1-8)
measure: Change in Total Sleep Time
timeFrame: Nightly (each night throughout study weeks 1-8)
measure: Change in Self-Reported Sleep
timeFrame: Daily (each morning throughout study weeks 1-8)
Other outcomes:
measure: Change in cognitive test battery performance
timeFrame: Daily: Baseline (throughout 1st-2nd study weeks) and Post-Treatment (throughout 8th study week)
measure: Adherence to clinical therapeutic prescription
timeFrame: Daily: during Intervention (throughout 3rd-7th study weeks) and Post-Treatment (throughout 8th study week)
measure: Change (pg/mL) in blood biomarkers of Alzheimer's-related dementia and Inflammation
timeFrame: Baseline (week 2) vs. Post-Treatment (8th week)
measure: Change in C-reactive Protein (CRP; mg/L)
timeFrame: Baseline (week 2) vs. Post-Treatment (8th week)
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The University of Arizona
name: Daniel Taylor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Space, Inc.
name: Daniel Gartenberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Orfeu M Buxton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: