Investigation of Using Non-Wearable Devices to Assess Sleep- Disordered Breathing in Hospitalized Patients With Schizophrenia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorTaipei Medical University Shuang Ho Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: observational group

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

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