STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

Not Applicable

Completed

• Conditions: Insomnia Chronic
• Interventions: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Active Comparator

• Registration Number: NCT03604380
• 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) 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 remote, randomized, controlled trial to assess feasibility and initial efficacy in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Participant must be 55 years of age or older.
• Participant must meet criteria for clinical insomnia - moderate severity based on the Insomnia Severity Index.
• Participant must be a fluent English speaker.
• Participant must have adequate visual, auditory, and motor capacity to use computerized intervention.
• Participant must have a computer and access to the Internet.

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Sleep duration scores on the Pittsburg Sleep Quality Index	6 months
Sleep efficiency scores on the Pittsburg Sleep Quality Index	6 months

Trial Locations

Locations (1)

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