STATE Trial: SusTained Attention Training to Enhance Sleep

Study Overview
=================
Brief Summary
-----------------
This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a randomized, controlled trial to assess feasibility and initial efficacy in this population.

Official Title
-----------------
STATE Trial: SusTained Attention Training to Enhance Sleep

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Other: Computerized Plasticity-Based Adaptive Cognitive Training
* Other: Commercially available computerized training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be between ages 55 and 80. Participant must meet current diagnostic criteria for Primary Insomnia Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Participant with hypertension must be undergoing treatment for this condition and on a stable medication regimen for hypertension for ≥ 8 weeks prior to screening. Participant must be a fluent English speaker Participant must have adequate visual, auditory, and motor capacity to use computerized intervention Participant must be willing to wear Microsoft Band 2 watch to track sleep patterns Exclusion Criteria: Participants with cognitive impairment, delirium or dementia, or evidence of cognitive impairment from a pre-existing cause. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment. Participants enrolled in another concurrent research study. Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician. Participants using computer-based cognitive training programs or has used them within a month of the consent date.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment<br>Computerized plasticity-based adaptive cognitive training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session. | Other: Computerized Plasticity-Based Adaptive Cognitive Training<br> <br> |
| Active Comparator: Active Comparator<br>Commercially available computerized training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session. | Other: Commercially available computerized training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index |  | 4 months | 
| Sleep duration obtained by actigraphy (Microsoft Band 2 watch) |  | 4 months | 
| Sleep duration obtained by sleep diary |  | 4 months |