FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

The purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. The secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.

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Key information

Conditions

Schizophrenia Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Schizophrenia Spectrum and Other Psychotic Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. It is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. These patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. N/A

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient diagnosed of schizophrenia
reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit
who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study
(or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.

Exclusion criteria

Patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires
who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome)
or included in another clinical study or trial that can interfere with the normal control of the disease.

Treatment and study plan

Functioning assessment

Other

The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)

Quality of sleep assessment

Other

The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)

Sponsors and collaborators

Lead sponsor

Janssen-Cilag, S.A.

Industry

Registry information

Official study title

Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jun 20, 2011
Registry last updated: Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed