Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH126357 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overnight polysomnography examinations | Behavioral | sleep lab for overnight polysomnography examinations |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Kimhy, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224206 | Result | 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. |
Not provided
Not provided
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).
Beginning 9 months and ending 36 months following article publication.
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.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 23, 2025 | |
| Reset | Jun 9, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 23, 2025 | Jun 9, 2025 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000080103 | Emotional Regulation |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
The neurocognitive evaluators who administer the neurocognitive battery (MCCB) will be blinded to sleep schedule.
| D001519 | Behavior |