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Application of Fiber - Optic Sensor - Based Physiological Sign Monitoring System in the Diagnosis of Obstructive Sleep Apnea and Sleep Staging: A Prospective Validation Study

Application of Fiber - Optic Sensor - Based Physiological Sign Monitoring System in the Diagnosis of Obstructive Sleep Apnea and Sleep Staging: A Prospective Validation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116427
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Interventions

Gold Standard Control Group:None
Multimodal Fusion Group:None
Single-Modality Group:None

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age range: 18-60 years old, outpatient or inpatient, regardless of gender; 2. Patients voluntarily participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with implanted cardiac pacemakers; 2. Patients with severe arrhythmias, atrial fibrillation, or other diseases that may significantly affect HRV; 3. Patients taking medications that may significantly affect autonomic nervous function; 4. Patients unable to remain generally still due to severe tremors caused by Parkinson's disease or other conditions; 5. Pregnant women during labor and delivery, including those planning a cesarean section, and breastfeeding women; 6. Patients with current psychiatric disorders (such as schizophrenia, depression, etc.), cognitive dysfunction, a history of epilepsy, or a history of substance abuse involving psychiatric drugs or anesthetics; 7. Patients with a history of myocardial infarction or unstable angina within 6 months prior to the screening period; 8. Patients with a heart rate or pulse =160 mmHg and/or diastolic BP >=100 mmHg) or hypotension (screening period: systolic BP <=90 mmHg and/or diastolic BP <=50 mmHg).

Design outcomes

Primary

MeasureTime frame
Sleep Stage Classification Accuracy;ensitivity and specificity of apnea/hypopnea detection;

Countries

China

Contacts

Public ContactShu Haihua

Guangdong Provincial People's Hospital

shuhaihua@hotmail.com+86 134 2753 6899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026