Using non‑wearable sensors to detect sleep‑disordered breathing in hospitalized people with schizophrenia
Investigation of Using Non-Wearable Devices to Assess Sleep- Disordered Breathing in Hospitalized Patients With Schizophrenia
This project tests whether non‑wearable sleep sensors can detect obstructive sleep apnea and whether apnea is linked to changes in symptoms for hospitalized people with schizophrenia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Taipei Medical University Shuang Ho Hospital Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT07192042 on ClinicalTrials.gov |
What this trial studies
This observational study will use a smart sensing pad based on noninvasive fiber optic physiological monitoring (nFOPT) to capture overnight sleep signals in psychiatric inpatients and compare findings with a simplified screening device (Belun Ring). Participants will also wear activity bands to record daytime activity and sleep behaviors, while nurses record observations every 30 minutes and clinicians perform routine psychiatric symptom assessments. Researchers will determine the prevalence and severity of sleep‑disordered breathing and analyze how OSA relates to psychiatric symptom changes during hospitalization. Statistical and machine‑learning methods will be used to explore correlations and build multimodal models to predict clinical trajectories.
Who should consider this trial
Good fit: Hospitalized adults aged 20–70 with DSM‑5 schizophrenia spectrum disorders who can provide informed consent (or have guardian consent) and are clinically stable at admission.
Not a fit: Patients already receiving CPAP therapy or those with other major central nervous system disorders or severe cognitive impairment that preclude participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could enable easier, noninvasive detection of obstructive sleep apnea in psychiatric inpatients and support earlier treatment to improve clinical outcomes and quality of life.
How similar studies have performed: Non‑wearable and simplified sleep sensors have been validated in general and outpatient populations, but their use and performance in hospitalized psychiatric patients remain relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New Taipei City
- Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jiunn-Kae Wang, MD, MSc
- Email: 14073@s.tmu.edu.tw
- Phone: +886970749758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.