Enhanced CBTi for Older Adult Sleep and Cognition

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).

Conditions

• Insomnia
• Alzheimers Disease Related Dementias

Interventions

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.

Sponsors & Collaborators

• University of Arizona

  collaborator OTHER

• Proactive Life Inc

  collaborator INDUSTRY

• Penn State University

  lead OTHER

Principal Investigators

• Daniel Taylor, Ph.D. · The University of Arizona

• Daniel Gartenberg, Ph.D. · Sleep Space, Inc.

• Orfeu M Buxton, Ph.D. · The Pennsylvania State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-16

Primary Completion

2023-06-14

Completion

2023-08-16

Countries

• United States

Study Locations