NCT05015803

Enhanced CBTi for Older Adult Sleep and Cognition

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• Alzheimers Disease Related Dementias

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CBTi with Application	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.
BEHAVIORAL	CBTi	Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician, with some application interface use.
BEHAVIORAL	Sleep Hygiene Education	Participants randomized to this study arm will experience sleep hygiene education and training, with some application interface use.

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-06-14
• Completion: 2023-08-16
• First posted: 2021-08-20
• Last updated: 2024-04-12

Locations

1 site across 1 country: United States