NCT05032963Completed
Neurocognition After Perturbed Sleep
Neurocognition After Perturbed Sleep (NAPS)
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 27 Aug 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 31 May 2024
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Schizophrenia
- NCT number
- NCT05032963
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 21 Sept 2021 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- REM behavior disorder, parasomnias)
Other
- DSM-5 alcohol/substance diagnosis (except nicotine) within the last 6 months
- Mental retardation
- Narcolepsy
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.