STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

NCT03604380 | Completed

• 1 other identifier: PSC-0510-18
• Study Type: interventional
• Target: 134
• 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) 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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (2)

• Sleep efficiency scores on the Pittsburg Sleep Quality Index

  6 months

• Sleep duration scores on the Pittsburg Sleep Quality Index

  6 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Other: Active Comparator

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

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

Experimental Treatment

Active Comparator OTHER

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

Active Comparator

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead

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 Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 27, 2018
• Study Start: July 10, 2018
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

US (1)