Overnight polysomnography examinations for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Schizophrenia
Overnight polysomnography examinations - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether sleep problems are associated with neurocognitive deficits in people with schizophrenia.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Schizophrenia

Study Objectives

This trial is evaluating whether Overnight polysomnography examinations will improve 2 primary outcomes in patients with Schizophrenia. Measurement will happen over the course of Day 16, immediate upon wakening.

Day 16
MATRICS Consensus Cognitive Battery (MCCB)
Day 15
Polysomnography

Trial Safety

Safety Progress

1 of 3

Other trials for Schizophrenia

Trial Design

2 Treatment Groups

Undisturbed Sleep
1 of 2
Restricted Sleep
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Overnight Polysomnography Examinations is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Restricted Sleep
Behavioral
4 hours sleep - Subjects randomized to the restricted sleep will be instructed to go to sleep at 3am and awoken at 7am.
Undisturbed Sleep
Behavioral
8 hours sleep - Subjects randomized to the undisturbed sleep will be instructed to go to sleep at 11pm, and awoken at 7am.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 15-16 during restricted sleep and undisturbed sleep
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly days 15-16 during restricted sleep and undisturbed sleep for reporting.

Who is running the study

Principal Investigator
D. K.
Prof. David Kimhy, Associate Professor
Icahn School of Medicine at Mount Sinai

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females or males age 18-50 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.

Patient Q&A Section

What are common treatments for schizophrenia?

"The main treatments for schizophrenia are medication and hospital care, although family therapy is sometimes used following the breakdown of social support. The severity of schizophrenia is related to treatment choice, the need (or motivation) for treatment and the social support available." - Anonymous Online Contributor

Unverified Answer

What is schizophrenia?

"Schizophrenia is a chronic psychotic disorder in which psychotic symptoms are generally present for a long period of time, are relatively stable, and are not adequately relieved by medication. Patients often exhibit cognitive and affective dysfunction. Schizophrenic patients are categorized in several different ways, including by age when onset, course, and disability.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of schizophrenia?

"Schizophrenia can result in symptoms such as loss of interest in art, low self-esteem, poor concentration, social withdrawal, low energy, feeling that the world is hostile, poor thinking and sensory distortions and hallucinations. Schizophrenia sometimes occurs before the first episode of psychosis and can then be hard to differentiate from other psychiatric disorders.\n" - Anonymous Online Contributor

Unverified Answer

How many people get schizophrenia a year in the United States?

"The number of Americans diagnosed with schizophrenia will increase over the time span. It takes 15.6 percent more schizophrenic individuals to become diagnosed over an 8-year span than over a 5-year span." - Anonymous Online Contributor

Unverified Answer

What causes schizophrenia?

"There is a strong effect of genetics and a much lower effect of pollution. The environment may be an important factor in childhood, but the mechanisms are probably not clearly understood. Most children, if not all, are born with schizophrenia, whereas in the general population only 1% are. In children, the age of onset is a factor. This suggests that schizophrenia is a developmental disorder." - Anonymous Online Contributor

Unverified Answer

Can schizophrenia be cured?

"Given that people with schizophrenia do not typically die of natural causes, these views should not be taken as evidence that schizophrenia cannot be cured. Moreover, many people in the public and healthcare sectors appear to value the views of those who believe that schizophrenia cannot be cured, and there appears to be little evidence for the views being held by the community at large." - Anonymous Online Contributor

Unverified Answer

Does schizophrenia run in families?

"It seems that schizophrenic mothers are a good genetic model in addition to schizophrenic fathers. There is also an association between a male first-degree relative with the occurrence of psychotic episodes. This association is stronger than a family history of psychotic episodes." - Anonymous Online Contributor

Unverified Answer

What is overnight polysomnography examinations?

"Overnight PSG evaluation can reveal changes of brain activity in sleep patterns and sleep stages during a day time session in patients who do not have obvious symptoms. We think that an overnight PSG can give more information to diagnose sleep disturbances in the patients and the usefulness of PSG evaluations in the clinical decisions." - Anonymous Online Contributor

Unverified Answer

Is overnight polysomnography examinations safe for people?

"In the majority of cases overnight PSGs were well tolerated and provided important new insight into people's sleep architecture and their neurological state during the sleep period." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving overnight polysomnography examinations?

"In our patients, no changes were observed between the two test conditions (even though we used a rigorous methodology in an attempt to reduce the noise inherent to polysomnography) as well as between both conditions and controls. In some patients, but not in the entire group, periodic changes, usually of short duration, were observed between NREM sleep and wakefulness: this could be due to NREM sleep-related events that did not reach the criteria. A future study on a larger sample size, using a randomisation procedure, would help clarify this issue." - Anonymous Online Contributor

Unverified Answer

Does overnight polysomnography examinations improve quality of life for those with schizophrenia?

"Results from a recent paper support previous suggestions that objectively measured sleep quality can benefit psychological wellbeing in people with psychotic disorders. The small absolute gain in the GCSQ score (1%) observed with OPA does not translate to a reduction in quality of life, but the increased incidence of severe sleep disturbances may have a negative impact on quality of life. Future research into treatment of sleep disorders will be necessary to investigate whether OPA is suitable as a treatment for sleep-related disturbance in people suffering from psychosis, or whether it is appropriate in only some patients." - Anonymous Online Contributor

Unverified Answer

How does overnight polysomnography examinations work?

"The PSG has no role in diagnosing a patient unless sleep studies are ordered for other reasons. On the other hand, the PSG can aid in the management of the patient, in particular when the patient has more than a few episodes per week, or if sleep studies indicate the presence of the sleep variant atonia. The PSG cannot provide a diagnosis or be used to rule out other sleep disorders which might be more obvious and require less invasive testing because of their relatively specific presentation, such as obstructive sleep apneas and circadian rhythm sleep disorders." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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