STATE Trial: SusTained Attention Training to Enhance Sleep – Remote

Overview

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.

Full Title of Study: “STATE Trial: SusTained Attention Training to Enhance Sleep (Phase I- Remote Trial Arm)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 4, 2020

Interventions

  • Other: Computerized Plasticity-Based Adaptive Cognitive Training
    • 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: Active Comparator
    • Commercially available computerized training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Arms, Groups and Cohorts

  • Experimental: Experimental Treatment
    • Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.
  • Active Comparator: Active Comparator
    • Commercially available computerized training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Clinical Trial Outcome Measures

Primary Measures

  • Sleep efficiency scores on the Pittsburg Sleep Quality Index
    • Time Frame: 6 months
  • Sleep duration scores on the Pittsburg Sleep Quality Index
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Posit Science Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Van Vleet, PhD, Principal Investigator, Posit Science Corporation

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