STATE Trial: SusTained Attention Training to Enhance Sleep

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Other: Commercially available computerized training; Other: Computerized Plasticity-Based Adaptive Cognitive Training

• Registration Number: NCT02921074
• Lead Sponsor: Posit Science Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Commercially available computerized training	Commercially available computerized training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.
Experimental Treatment	Computerized Plasticity-Based Adaptive Cognitive Training	Computerized plasticity-based adaptive cognitive training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Primary Outcome Measures

Name	Time	Method
Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index	4 months
Sleep duration obtained by actigraphy (Microsoft Band 2 watch)	4 months
Sleep duration obtained by sleep diary	4 months

Trial Locations

Locations (1)

Posit Science Corporation; 🇺🇸 San Francisco, California, United States