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

NCT07192042 | Recruiting DMC

• 1 other identifier: N202505085
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia and Schizophrenia Spectrum Psychosis

Keywords

Schizophrenia; Sleep- Disordered Breathing; Obstructive Sleep Apnea; Non-Wearable Devices; Hospitalized Patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From Day 1 through study completion, an average of 3 weeks

Secondary Outcomes (2)

• Positive and Negative Syndrome Scale (PANSS)

  From Day 1 through study completion, an average of 3 weeks

• Brief Psychiatric Rating Scale (BPRS)

  From Day 1 through study completion, an average of 3 weeks

Study Arms (1)

observational group

schizophrenia

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with schizophrenia in the acute psychiatric ward at Shuang Ho Hospital, TMU, Taiwan

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Jiunn-Kae Wang, MD, MSc

CONTACT

+886970749758; 14073@s.tmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 25, 2025
• Study Start: September 9, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)