STATE Trial: SusTained Attention Training to Enhance Sleep

NCT02921074 | Completed

• 1 other identifier: PSC-1009-16
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

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

Other: Commercially available computerized training

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

Experimental Treatment

Commercially available computerized training OTHER

Active Comparator

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: March 1, 2016
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)