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Validation study of a new type of sleep monitoring device for diagnosis of sleep-disordered breathing

Validation study of a new type of sleep monitoring device for diagnosis of sleep-disordered breathing

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093764
Enrollment
Unknown
Registered
2024-12-11
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Sleep-disordered breathing

Interventions

Gold Standard:Overnight PSG apnea hypopnea index (AHI) >=5 (times/hour)
Index test:Overnight millimeter-wave radar sleep breathing monitoring (Tsingray) collects sleep monitoring indicators, It includes Apnea hypopnea index (AHI), mean arterial oxygen saturation (SaO2), m

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Complete overnight polysomnographic sleep monitoring (PSG); 2.Total sleep time (TST) >=4 hours; 3.Rapid eye movement (REM) sleep duration >=15min;

Exclusion criteria

Exclusion criteria: 1.Basic information is incomplete; 2.Communication breakdown, inability to cooperate;

Design outcomes

Primary

MeasureTime frame
Apnea hypopnea index, AHI;—

Secondary

MeasureTime frame
sleep structure;Accuracy;Sensitivity;Specificity;—

Countries

China

Contacts

Public ContactWenbin Lei

The First Affiliated Hospital,Sun Yat-sen University

leiwb@mail.sysu.edu.cn+86 13922113299

Outcome results

None listed

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