STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

Sponsor

Posit Science Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03604380

Collaborator

(none)

134

Enrollment

Location

Arms

27.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Chronic	Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Active Comparator	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2018

Actual Primary Completion Date :

Nov 4, 2020

Actual Study Completion Date :

Nov 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Treatment 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 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.	Other: Active Comparator Commercially available computerized training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.

Arm

Intervention/Treatment

Experimental: Experimental Treatment

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

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.

Other: Active Comparator

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

Outcome Measures

Primary Outcome Measures

Sleep efficiency scores on the Pittsburg Sleep Quality Index [6 months]
Sleep duration scores on the Pittsburg Sleep Quality Index [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Posit Science Corporation	San Francisco	California	United States	94111

Sponsors and Collaborators

Posit Science Corporation

Investigators

Principal Investigator: Thomas Van Vleet, PhD, Posit Science Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Posit Science Corporation

ClinicalTrials.gov Identifier:

NCT03604380

Other Study ID Numbers:

PSC-0510-18

First Posted:

Jul 27, 2018

Last Update Posted:

Dec 2, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Dec 2, 2020