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Clinical Research on an Automatic Diagnosis System for Daytime OSA Based on Acoustic Features

Clinical Research on an Automatic Diagnosis System for Daytime OSA Based on Acoustic Features

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077624
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-21

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:PSG(Polysomnography)
Index test:AHI(Apnea-Hypopnea Index)

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 20 to 70 years old, regardless of gender; (2) Complete overnight PSG monitoring in our hospital, and if the total sleep time of the night exceeds 4 hours(PSG is recorded as REM and NREM sleep); (3) The subjects voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) PSG indicates central apnea index = 5 times/hour; (2) Subjects with a history of vocal cord surgery, vocal cord polyps or other incurable vocal cord diseases, and discomfort symptoms of vocal organs in the past 2 weeks, including hoarseness, sore throat, dry throat, swallowing pain, throat itching and coughing, phlegm in the throat, foreign body sensation in the throat, pronunciation fatigue, inappropriate tone and volume, difficulty breathing, and interruption of voice; (3) There are obvious craniofacial deformities, hearing disorders, and speech/articulation disorders; (4) Subjects with severe physical diseases, hemodynamic instability, and untreated or unstable mental illnesses; (5) There are any situations that are deemed unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;Confusion Matrix;Receiver Operating Characteristic Curve(ROC);

Secondary

MeasureTime frame
Mean Absolute Error;Pearson Correlation Coefficient;

Countries

China

Contacts

Public ContactYu Huan

Huashan Hospital, Fudan University

dr.yuhuan@163.com+86 21 5460 2182

Outcome results

None listed

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