STATE Trial: SusTained Attention Training to Enhance Sleep

NCT ID: NCT02921074

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-04-10

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Treatment

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

Group Type: EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

Active Comparator

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

Group Type: ACTIVE_COMPARATOR

Commercially available computerized training

Intervention Type: OTHER

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

Commercially available computerized training

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Posit Science Corporation

San Francisco, California, United States

Countries

United States

Other Identifiers

PSC-1009-16

Identifier Type: -

Identifier Source: org_study_id