STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

Posit Science

Status: Completed

Conditions: Insomnia Chronic

Treatments: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Active Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03604380

PSC-0510-18

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

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

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

Active Comparator group

Description:

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

Treatment:

Other: Active Comparator