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STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604380
Acronym
STATE
Enrollment
134
Registered
2018-07-27
Start date
2018-07-10
Completion date
2020-11-04
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Chronic

Brief summary

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.

Interventions

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.

OTHERActive Comparator

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

Sponsors

Posit Science Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Sleep efficiency scores on the Pittsburg Sleep Quality Index6 months
Sleep duration scores on the Pittsburg Sleep Quality Index6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026