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

NCT ID: NCT07192042

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2026-04-30

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.

Detailed Description

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.

Conditions

Schizophrenia and Schizophrenia Spectrum Psychosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

observational group

schizophrenia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jiunn-Kae Wang, MD, MSc

Role: CONTACT

14073@s.tmu.edu.tw

+886970749758

Facility Contacts

Jiunn-Kae Wang, MD, MSc

Role: primary

14073@s.tmu.edu.tw

+886970749758

Other Identifiers

N202505085

Identifier Type: -

Identifier Source: org_study_id