Neurocognition After Perturbed Sleep

ID#: NCT05032963

Age: 18 - 60 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 01, 2021

End Date: May 01, 2023

Contact Information:
David Kimhy, PhD
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.

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