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Neurocognition After Perturbed Sleep (NAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05032963
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Kimhy, Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Overnight polysomnography examinations Not Applicable

Detailed Description:

Individuals with SZ display a broad range of neurocognitive difficulties that have been identified as major determinants of poor functioning and disability, thus representing an important public health concern and a focal target for interventions. Extensive research literatures converge in highlighting the critical role insomnia and sleep disturbances play in degrading neurocognitive functioning. Such sleep disturbances result in clinical presentations similar to neurocognitive difficulties commonly observed in people with SZ. While insomnia and sleep disturbances are highly prevalent in people with SZ, there are scant data on the impact of sleep disturbances on neurocognition in SZ, and no data quantifying their influence on daily functioning. Thus, sleep disturbances remain poorly understood and modeled in SZ, their impact is rarely considered in clinical trials, and they remain largely unaddressed by clinicians. To address this gap in knowledge, the primary aim of this study is to characterize sleep in individuals with SZ and quantify its impact on neurocognition and daily functioning. Employing an experimental, within-person, repeated assessment design, the study team will characterize sleep architecture, duration, and quality along with cognitive, electrophysiological, biomarkers and daily functioning sequelae in 40 individuals with SZ. Participants will first complete a week-long, in-home characterization of sleep duration and quality using actigraphy and a sleep diary. Next, they will complete two overnight polysomnography examinations employing two sleep schedules:

1) undisturbed sleep; and 2) restricted sleep (4 hours). As part of these assessments, participants will provide blood samples for biomarkers analyses and complete EEG-indexed memory tasks pre- and post-sleep, along with a post-sleep battery of neurocognitive functioning.

Finally, participants will complete a 3-day ambulatory assessment using actigraphy and smartphones to explore the impact of each sleep schedule on "real-world" daily functioning including symptoms, emotion regulation, and mood.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The neurocognitive evaluators who administer the neurocognitive battery (MCCB) will be blinded to sleep schedule.
Primary Purpose: Basic Science
Official Title: Neurocognition After Perturbed Sleep (NAPS)
Actual Study Start Date : September 21, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Undisturbed Sleep
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
sleep lab for overnight polysomnography examinations
Experimental: Restricted Sleep
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
sleep lab for overnight polysomnography examinations


Outcome Measures
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Primary Outcome Measures :
  1. MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Day 2, immediate upon wakening ]
    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.

  2. MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Day 16, immediate upon wakening ]
    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.

  3. Polysomnography [ Time Frame: Days 1-2 during restricted sleep and undisturbed sleep ]
    Polysomnography will be used to characterize sleep including - latency, duration, continuity, and architecture assessed during over a night sleep.

  4. Polysomnography [ Time Frame: Days 15-16 during restricted sleep and undisturbed sleep ]
    Polysomnography will be used to characterize sleep including - latency, duration, continuity, and architecture assessed during over a night sleep.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032963


Contacts
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Contact: David Kimhy, PhD 212-585-4656 david.kimhy@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: David Kimhy, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: David Kimhy, PhD Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: David Kimhy, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05032963    
Other Study ID Numbers: GCO 20-1697
1R21MH126357 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Kimhy, Icahn School of Medicine at Mount Sinai:
Schizophrenia
Sleep
Cognition
Mood
 Emotion Regulation
Functioning
Psychosis
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders