SchizophreniaNAPSNCT05032963
Neurocognition After Perturbed Sleep
A study testing Overnight polysomnography examinations in people with Schizophrenia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Overnight polysomnography examinations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Neurocognition After Perturbed Sleep (NAPS)
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.
Read the 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:
- 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.
- Conditions
- Schizophrenia
- Being tested
- Overnight polysomnography examinations
- Keywords
- Schizophrenia, Sleep, Cognition, Mood, Emotion Regulation, Functioning, Psychosis
- Medical subject headings
- Schizophrenia, Emotional Regulation, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight polysomnography examinationsBehavioural
sleep lab for overnight polysomnography examinations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Overnight polysomnography examinations |
| 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. Receives: Behavioral: Overnight polysomnography examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 15-16 during restricted sleep and undisturbed sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start21 Sep 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Kimhy, Icahn School of Medicine at Mount Sinai
- Investigators
- David Kimhy, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032963
- Sponsor's protocol ID
- GCO 20-1697
- Other IDs
- 1R21MH126357
- Acronym
- NAPS
- Status last verified
- Feb 2025
- First submitted
- 27 Aug 2021
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 35224206
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognition After Perturbed Sleep (NAPS)
- ClinicalTrials.gov ID
- NCT05032963
- Acronym / sponsor ID
- NAPS / GCO 20-1697
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Sleep, Cognition, Mood, Emotion Regulation, Functioning, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undisturbed Sleep | Active comparator | Behavioral: Overnight polysomnography examinations8 hours sleep - Subjects randomized to the undisturbed sleep will be instructed to go to sleep at 11pm, and awoken at 7am. |
| Restricted Sleep | Experimental | Behavioral: Overnight polysomnography examinations4 hours sleep - Subjects randomized to the restricted sleep will be instructed to go to sleep at 3am and awoken at 7am. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overnight polysomnography examinationssleep lab for overnight polysomnography examinations | Behavioural | Restricted Sleep, Undisturbed Sleep |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 35224206Kimhy 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kimhy, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight polysomnography examinations in people with Schizophrenia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) (time frame: Day 2, immediate upon wakening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.