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Sleep Disturbance Impact on Schizophrenia (NAPS Trial)
N/A
Recruiting
Led By David Kimhy, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15-16 during restricted sleep and undisturbed sleep
Awards & highlights
NAPS Trial Summary
This trial will investigate how sleep disturbances affect people with schizophrenia, in terms of cognitive function and daily life.
Who is the study for?
This trial is for adults aged 18-60 with schizophrenia, schizoaffective, or schizophreniform disorder who have been on stable antipsychotic medication. They must understand the study's risks and benefits. Excluded are those with certain mental disorders, recent substance abuse, poor English literacy, medications affecting sleep (other than antipsychotics), significant head trauma history, severe disorganization symptoms, safety-critical jobs, certain medical conditions or irregular sleep patterns.Check my eligibility
What is being tested?
The study aims to assess how disturbed sleep affects neurocognition and daily functioning in individuals with schizophrenia. Participants will undergo overnight polysomnography examinations to monitor their sleep patterns and evaluate any cognitive impairments related to their sleeping difficulties.See study design
What are the potential side effects?
Since this trial involves monitoring rather than medication intervention, there are no direct side effects from treatments like drugs. However, participants may experience discomfort or inconvenience due to the overnight stay and equipment used for polysomnography.
NAPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia or a related disorder.
Select...
I've been on the same antipsychotic medication for at least 7 weeks.
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I am between 18 and 60 years old.
NAPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 15-16 during restricted sleep and undisturbed sleep
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 15-16 during restricted sleep and undisturbed sleep
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MATRICS Consensus Cognitive Battery (MCCB)
Polysomnography
NAPS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted SleepExperimental Treatment1 Intervention
4 hours sleep - Subjects randomized to the restricted sleep will be instructed to go to sleep at 3am and awoken at 7am.
Group II: Undisturbed SleepActive Control1 Intervention
8 hours sleep - Subjects randomized to the undisturbed sleep will be instructed to go to sleep at 11pm, and awoken at 7am.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,659 Total Patients Enrolled
249 Trials studying Schizophrenia
89,395 Patients Enrolled for Schizophrenia
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,236 Total Patients Enrolled
6 Trials studying Schizophrenia
461 Patients Enrolled for Schizophrenia
David Kimhy, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
144 Total Patients Enrolled
2 Trials studying Schizophrenia
144 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on sleep medications, except for antipsychotics.I haven't started any new medications or changed doses in the last month that affect thinking.I have been diagnosed with schizophrenia or a related disorder.I've been on the same antipsychotic medication for at least 7 weeks.I work in a job where staying alert is critical for safety.I do not have untreated thyroid issues or severe mental/neurological conditions.I have had a seizure or head injury with unconsciousness over 10 minutes affecting my thinking.I understand all the potential risks and benefits of the study.I am between 18 and 60 years old.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Undisturbed Sleep
- Group 2: Restricted Sleep
Schizophrenia Patient Testimony for trial: Trial Name: NCT05032963 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for volunteers to join this research endeavor?
"As stated on clinicaltrials.gov, this medical research is actively hunting for new participants with the latest update to its listing occurring April 4th 2022. The initial posting of the trial was September 21st 2021."
Answered by AI
Does the age criterion for this clinical trial permit individuals aged 35 and above?
"In accordance with the requirements for this experiment, participants must fall between 18 and 50 years of age."
Answered by AI
How many participants have signed up for this investigation thus far?
"Affirmative. According to information published on clinicaltrials.gov, this research project is actively seeking candidates and was first posted on September 21st 2021. The study requires 40 individuals spread across a single site and the details were updated most recently on April 4th 2022."
Answered by AI
Is there any way I can join this research project?
"Candidates who are between 18 and 50 years old, as well as have a diagnosis of schizophrenia, may qualify for this study. Specifically, 40 people will be selected to participate."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have schizophrenia and sleep apnea.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Icahn School of Medicine at Mount Sinai: < 48 hours
Average response time
- < 2 Days
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