STATE Trial: SusTained Attention Training to Enhance Sleep

Posit Science

Status: Completed

Conditions: Insomnia

Treatments: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Commercially available computerized training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02921074

PSC-1009-16

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

Active Comparator group

Description:

Commercially available computerized training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Treatment:

Other: Commercially available computerized training