STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

Insomnia Chronic Clinical Trial

— STATE  

Official title:

STATE Trial: SusTained Attention Training to Enhance Sleep (Phase I- Remote Trial Arm)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604380
• Other study ID #: PSC-0510-18
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Posit Science Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency scores on the Pittsburg Sleep Quality Index		6 months
Primary	Sleep duration scores on the Pittsburg Sleep Quality Index		6 months