Schizophrenia and Schizophrenia Spectrum PsychosisIUNWDNCT07192042
Investigation of Using Non-Wearable Devices to Assess Sleep- Disordered Breathing in Hospitalized Patients With Schizophrenia
An observational study of Schizophrenia and Schizophrenia Spectrum Psychosis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Schizophrenia and Schizophrenia Spectrum Psychosis
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with schizophrenia in the acute psychiatric ward at Shuang Ho Hospital, TMU, Taiwan
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City
Jiunn-Kae Wang, MD, MSc, +886970749758, 14073@s.tmu.edu.tw
About this study
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.
Read the 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.
- Keywords
- Schizophrenia, Sleep- Disordered Breathing, Obstructive Sleep Apnea, Non-Wearable Devices, Hospitalized Patients
- Medical subject headings
- Schizophrenia, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational group | schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Day 1 through study completion, an average of 3 weeks
Secondary outcomes (2)
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.
Measured: From Day 1 through study completion, an average of 3 weeks
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.
Measured: From Day 1 through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start9 Sep 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Schizophrenia Spectrum PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192042
- Sponsor's protocol ID
- N202505085
- Acronym
- IUNWD
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Using Non-Wearable Devices to Assess Sleep- Disordered Breathing in Hospitalized Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07192042
- Acronym / sponsor ID
- IUNWD / N202505085
- Keywords
- Schizophrenia, Sleep- Disordered Breathing, Obstructive Sleep Apnea, Non-Wearable Devices, Hospitalized Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | –schizophrenia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with schizophrenia in the acute psychiatric ward at Shuang Ho Hospital, TMU, Taiwan
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploring the Prevalence of Obstructive Sleep Apnea (OSA) in Patients with Schizophrenia
Time frame: From Day 1 through study completion, an average of 3 weeks
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
Time frame: From Day 1 through study completion, an average of 3 weeks
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.
2 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: From Day 1 through study completion, an average of 3 weeks
Brief Psychiatric Rating Scale (BPRS)
Time frame: From Day 1 through study completion, an average of 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizophrenia Spectrum Psychosis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiunn-Kae Wang, MD, MSc (+886970749758, 14073@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the Prevalence of Obstructive Sleep Apnea (OSA) in Patients with Schizophrenia (time frame: From Day 1 through study completion, an average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.