Schizophrenia Clinical Trial
— NAPSOfficial title:
Neurocognition After Perturbed Sleep (NAPS)
Verified date | April 2024 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 11pmĀ±2 hours) - Participation in the past 3 months in cognition study |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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