STATE Trial: SusTained Attention Training to Enhance Sleep - Remote (STATE)

November 30, 2020 updated by: Posit Science Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94111
        • Posit Science Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Posit Science Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PSC-0510-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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