Neurocognition After Perturbed Sleep

NCT05032963 | Completed

• 2 other identifiers: GCO 20-16971R21MH126357
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with schizophrenia display a wide range of neurocognitive difficulties resulting in functional impairment and disability. Extensive evidence indicates insomnia and sleep disturbances play a substantial role in degrading cognitive functioning. However, the putative impact of insomnia and sleep disturbances on neurocognition and daily functioning has not been investigated in people with schizophrenia. The goal of this study is to characterize sleep in individuals with schizophrenia and quantify its impact on neurocognition and daily functioning.

Conditions

Schizophrenia

Keywords

Schizophrenia; Sleep; Cognition; Mood; Emotion Regulation; Functioning; Psychosis

Outcome Measures

Primary Outcomes (4)

• MATRICS Consensus Cognitive Battery (MCCB)

  The composite score of the MATRICS Consensus Cognitive Battery (MCCB) will serve as a primary neurocognitive outcome. Neurocognitive functioning is indexed on the MCCB via T scores, with a mean of 50 and a SD of 10. Thus, higher scores indicate better neurocognitive performance, with T-scores of 70+ (i.e., 2 SD's over the mean) suggestive of exceptionally strong neurocognitive abilities.

  Day 2, immediate upon wakening

• MATRICS Consensus Cognitive Battery (MCCB)

  The composite score of the MATRICS Consensus Cognitive Battery (MCCB) will serve as a primary neurocognitive outcome. Neurocognitive functioning is indexed on the MCCB via T scores, with a mean of 50 and a SD of 10. Thus, higher scores indicate better neurocognitive performance, with T-scores of 70+ (i.e., 2 SD's over the mean) suggestive of exceptionally strong neurocognitive abilities.

  Day 16, immediate upon wakening

• Polysomnography

  Polysomnography will be used to characterize sleep including - latency, duration, continuity, and architecture assessed during over a night sleep.

  Days 1-2 during restricted sleep and undisturbed sleep

• Polysomnography

  Polysomnography will be used to characterize sleep including - latency, duration, continuity, and architecture assessed during over a night sleep.

  Days 15-16 during restricted sleep and undisturbed sleep

Study Arms (2)

Undisturbed Sleep

ACTIVE COMPARATOR

8 hours sleep - Subjects randomized to the undisturbed sleep will be instructed to go to sleep at 11pm, and awoken at 7am.

Behavioral: Overnight polysomnography examinations

Restricted Sleep

EXPERIMENTAL

4 hours sleep - Subjects randomized to the restricted sleep will be instructed to go to sleep at 3am and awoken at 7am.

Behavioral: Overnight polysomnography examinations

Interventions

Overnight polysomnography examinations BEHAVIORAL

sleep lab for overnight polysomnography examinations

Restricted Sleep; Undisturbed Sleep

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females or males age 18-60 years
• DSM-5 diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder
• Taking antipsychotic medication for \>7 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in the last 3 months
• Capacity to understand all the potential risks and benefits of the study.

You may not qualify if:

• DSM-5 alcohol/substance diagnosis (except nicotine) within the last 6 months
• Taking medications affecting sleep propensity or architecture (other than antipsychotic medication)
• Initiation of medications known to impact cognition in previous 4 weeks or any change in doses during this period
• History of seizures/head trauma with loss of consciousness (\>10 min) resulting in cognitive sequelae
• Medical or neurological conditions that could interfere with participation (e.g., untreated hypothyroidism
• Mental retardation
• Narcolepsy
• REM behavior disorder, parasomnias)
• Pregnant/ nursing
• Serious homicidal/suicidal risk (past 6 months)
• Moderate or more severe disorganization (PANSS≥4)
• Poor English reading ability (WTAR\<7)
• Individuals employed as vehicle drivers/train operators or have occupations in which lapses in sustained vigilance would compromise safety
• Night shift workers or those with irregular sleep-wake rhythms (based on the week-long home actigraphy; i.e., average bedtime of 11pm±2 hours)
• Participation in the past 3 months in cognition study

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Kimhy D, Ospina L, Beck-Felts K, Fakhoury A, Mullins AE, Varga AW. The Impact of Sleep on Neurocognition and Functioning in Schizophrenia-Is It Time to Wake-Up? J Psychiatr Brain Sci. 2022;7:e220001. doi: 10.20900/jpbs.20220001. Epub 2022 Jan 25.

  PMID: 35224206 RESULT

MeSH Terms

Conditions

Schizophrenia; Emotional Regulation; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• David Kimhy, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neurocognitive evaluators who administer the neurocognitive battery (MCCB) will be blinded to sleep schedule.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: September 21, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Informed Consent Form (ICF) Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. The type of analysis would be to achieve aims in the approved proposal. Data will be made available by contacting the PI via email.

Locations

US (1)