MedTrace Logo

Sleep Quality, Cognitive Performance, and Computerized Cognitive Training

NCT06328140 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-05-04

No results posted yet for this study

Summary

Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.

Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.

Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as well

In previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.

Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy.

Conditions

Interventions

DRUG

Lurasidone

Daily medication treatment

DRUG

FDA Approved antidepressant treatment

Daily treatment with an FDA approved antidepressant

Sponsors & Collaborators

  • Sumitomo Pharmaceuticals America

    collaborator INDUSTRY

  • George West Mental Health Foundation d/b/a Skyland Trail

    lead OTHER

Principal Investigators

  • Ben W Hunter, MD · Skyland Trail

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-01-22
Completion
2025-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06328140 on ClinicalTrials.gov