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Completed

NCT Number: NCT03604380

STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

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.

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

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 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.

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

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

Other

Commercially available computerized training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Primary outcomes

  1. Sleep efficiency scores on the Pittsburg Sleep Quality Index

    Time frame: 6 months

  2. Sleep duration scores on the Pittsburg Sleep Quality Index

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Registry information

Official study title

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

Acronym: STATE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Dec 2, 2020

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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