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Completed

NCT Number: NCT02921074

STATE Trial: SusTained Attention Training to Enhance Sleep

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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Commercially available computerized training

Other

Primary outcomes

  1. Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index

    Time frame: 4 months

  2. Sleep duration obtained by actigraphy (Microsoft Band 2 watch)

    Time frame: 4 months

  3. Sleep duration obtained by sleep diary

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • University of California, San Francisco

Registry information

Acronym: STATE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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