An observational study in Schizophrenia and Schizophrenia Spectrum Psychosis, sponsored by Taipei Medical University Shuang Ho Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Taipei Medical University Shuang Ho Hospital · Observational
This research project aims to evaluate the prevalence of comorbid OSA and its impact on disease progression among hospitalized schizophrenia patients using non-wearable devices.
Schizophrenia patients frequently experience sleep disorders and circadian rhythm disruptions, with Obstructive Sleep Apnea (OSA) being particularly prevalent. Evidence indicates that schizophrenia patients have approximately twice the risk of developing OSA compared to the general population, and comorbid OSA may worsen clinical outcomes, reduce quality of life, and increase mortality. Traditional OSA diagnosis relies on overnight Polysomnography (PSG), which is costly, difficult to implement, and associated with lower compliance among psychiatric patients, leading to delayed detection and treatment.
This study aims to evaluate the prevalence of comorbid OSA and its impact on disease progression in hospitalized schizophrenia patients using non-wearable monitoring devices. A smart sensing pad based on Noninvasive Fiber Optic Physiological Monitoring Technology (nFOPT) will be employed to capture sleep physiological signals, while OSA severity will be compared with assessments from a simplified sleep-disordered breathing screening device (Belun Ring). The study will incorporate clinical psychiatric symptom evaluations, nurses' observations recorded every 30 minutes during hospitalization, and data from wearable bands capturing daytime activity levels and sleep behaviors. Statistical and machine learning analyses will be applied to examine correlations between OSA severity and changes in psychiatric symptoms and to develop multimodal prediction models.
Expected outcomes include: (1) determination of the prevalence and severity distribution of OSA among hospitalized schizophrenia patients, (2) characterization of the relationship between OSA severity and psychiatric symptom changes, and (3) validation of non-wearable fiber optic monitoring technology for early screening and risk prediction. The application of clinically feasible, non-wearable devices is intended to enhance detection of comorbid sleep-disordered breathing in schizophrenia and support timely diagnostic and therapeutic interventions, ultimately improving patient outcomes and quality of life.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 80 is below the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 102 studies on the registry; 19 are open to participants now.
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Hospitalized patients with schizophrenia in the acute psychiatric ward at Shuang Ho Hospital, TMU, Taiwan
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
schizophrenia
Exploring the Prevalence of Obstructive Sleep Apnea (OSA) in Patients with Schizophrenia
The prevalence and distribution of OSA across different severity levels will be evaluated using the apnea-hypopnea index/respiratory event index derived from the Belun Ring (bAHI). Belun Ring is a wearable, non-invasive device designed to continuously monitor physiological signals during daily life and sleep. It uses optical and motion sensors to provide detailed data on autonomic and sleep-related parameters. The severity of OSA is categorized based on the bAHI as follows: Normal: bAHI \< 5 events/hour; Mild OSA: bAHI between 5 and 15 events/hour; Moderate OSA: bAHI between 15 and 30 events/hour; Severe OSA: bAHI \> 30 events/hour.
Time frame: From Day 1 through study completion, an average of 3 weeks
Non-invasive Fiber Optic Physiological Monitoring (nFOPT) for respiratory patterns
A novel non-invasive monitoring technique that uses fiber optic sensors to continuously measure physiological signals with high sensitivity and stability. This technology aims to investigate respiratory patterns during sleep. Higher irregularity in respiratory patterns may indicate poorer physiological regulation, while stable and coherent signals suggest healthier sleep and autonomic function.
Time frame: From Day 1 through study completion, an average of 3 weeks
Positive and Negative Syndrome Scale (PANSS)
A clinician-administered scale designed to assess the severity of positive, negative, and general psychopathology symptoms in schizophrenia. The PANSS consists of 30 items rated on a 7-point Likert scale (1 = absent to 7 = extreme). Total scores range from 30 to 210, with higher scores indicating more severe psychiatric symptoms. Subscales include: Positive symptom scale (7 items): evaluates hallucinations, delusions, and other positive symptoms. Negative symptom scale (7 items): evaluates blunted affect, social withdrawal, and other negative symptoms. General psychopathology scale (16 items): evaluates mood, anxiety, cognitive symptoms, and other general psychopathology. Higher total or subscale scores indicate greater symptom severity. The PANSS is widely used to monitor symptom changes during hospitalization or intervention.
Time frame: From Day 1 through study completion, an average of 3 weeks
Brief Psychiatric Rating Scale (BPRS)
A clinician-administered scale designed to assess psychiatric symptom severity in patients with schizophrenia and other psychotic disorders. The BPRS includes 18-24 items (depending on version), each rated on a 7-point Likert scale (1 = not present to 7 = extremely severe). Key symptom domains include: Positive symptoms: hallucinations, delusions, thought disorder. Negative symptoms: emotional withdrawal, blunted affect, motor retardation. Affective symptoms: anxiety, depression, hostility. Total scores range from 18 (minimal symptoms) to 126 (maximum symptom severity), with higher scores indicating greater symptom severity. The BPRS is commonly used to monitor changes in psychiatric symptoms over time and in response to interventions.
Time frame: From Day 1 through study completion, an average of 3 weeks
Plan to share: Yes — Study Protocol
Supporting information: Study protocol
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