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Behavioural Intervention

Remote Cognitive Training for Insomnia (rSTATE Trial)

N/A

Waitlist Available

Led By Thomas Van Vleet, PhD

Research Sponsored by Posit Science Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with an Insomnia disorder diagnosis per DSM-V

Be older than 65 years old

Must not have

Participants with a seizure disorder

Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 weeks and at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a computerized program called rSTATE to see if it can help older adults with insomnia improve their sleep and brain health, and stay independent longer.

Who is the study for?

This trial is for older adults who are experiencing insomnia. Participants should be interested in trying a computerized cognitive training program to improve their sleep and brain health, with the goal of maintaining independence.

What is being tested?

The study is testing rSTATE, a computerized cognitive training designed to help regulate sleep patterns in older adults with insomnia. It also includes education on good sleep practices. The effectiveness of this program will be compared against standard treatments.

What are the potential side effects?

Since the intervention involves non-invasive cognitive training and educational components, significant side effects are not anticipated. However, participants may experience fatigue or frustration if they find the exercises challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with insomnia according to DSM-V.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a seizure disorder.

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I have sleep issues not caused by a primary sleep disorder, like restless legs.

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I am currently undergoing or have recently completed cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 weeks and at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 weeks and at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 weeks and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Complex Set-Shifting Score

Gradual-Onset Continuous Performance Task Score

Sleep Quality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental TreatmentExperimental Treatment1 Intervention

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, \~36 minutes per session.

Group II: Active ComparatorActive Control1 Intervention

Sleep hygiene education

0 / 4Eligibility criteria met