STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

Study Overview
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Brief Summary
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This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) 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 remote, randomized, controlled trial to assess feasibility and initial efficacy in this population.

Official Title
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STATE Trial: SusTained Attention Training to Enhance Sleep (Phase I- Remote Trial Arm)

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Other: Computerized Plasticity-Based Adaptive Cognitive Training
* Other: Active Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be 55 years of age or older. Participant must meet criteria for clinical insomnia - moderate severity based on the Insomnia Severity Index. Participant must be a fluent English speaker. Participant must have adequate visual, auditory, and motor capacity to use computerized intervention. Participant must have a computer and access to the Internet. Exclusion Criteria: 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 using computer-based cognitive training programs or has used them within a month of the consent date.

Ages Eligible for Study
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Minimum Age: 55 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
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency scores on the Pittsburg Sleep Quality Index |  | 6 months | 
| Sleep duration scores on the Pittsburg Sleep Quality Index |  | 6 months |