STATE Trial: SusTained Attention Training to Enhance Sleep

Insomnia Clinical Trial

— STATE  

Official title:

STATE Trial: SusTained Attention Training to Enhance Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921074
• Other study ID #: PSC-1009-16
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 10, 2018

Study information

• Verified date: May 2018
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training

• Commercially available computerized training

Locations

Country	Name	City	State
United States	Posit Science Corporation	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Posit Science Corporation	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index		4 months
Primary	Sleep duration obtained by actigraphy (Microsoft Band 2 watch)		4 months
Primary	Sleep duration obtained by sleep diary		4 months