About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Participants must be between 20 and 70 years old.
Diagnostic Criteria: Schizophrenia spectrum disorders, including schizophrenia, schizoaffective disorder, and schizophreniform disorder, diagnosed according to DSM-5 criteria and confirmed with the MINI 7.0 (Chinese version).
Clinical Stability and Informed Consent: At the time of admission, participants should be in a relatively stable condition, able to understand the study procedures, and capable of providing written informed consent. If patients are unable to fully comprehend due to illness severity or cognitive limitations, consent may be obtained from a legal guardian or family member, with subsequent confirmation of consent by the patient once their condition improves.
Disqualifiers
Treatment-related: Patients who are currently receiving continuous positive airway pressure (CPAP) therapy for OSA.
Other Major Central Nervous System Disorders: Presence of other serious conditions that may significantly affect central nervous system function, aside from schizophrenia, such as major depressive disorder or bipolar disorder.
Severe Medical Illnesses: Including, but not limited to, malignant tumors, end-stage cardiopulmonary disease, neuromuscular disorders severely affecting motor or respiratory function, uncontrolled epileptic seizures, or other serious medical conditions that prevent patients from sleeping in the supine position.
Clinical Judgment: Patients deemed unsuitable for participation due to clinical conditions (e.g., agitation, non-cooperation, or other safety concerns).
Trial population
Hospitalized patients with schizophrenia in the acute psychiatric ward at Shuang Ho Hospital, TMU, Taiwan
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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