Sleep respiratory monitoring and auxiliary diagnosis of sleep disorders
Conditions
Interventions
Gold Standard:Manual scoring results of polysomnography data by the sleep technician.
Index test:Sleep Respiratory Monitoring System
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Participants >= 18 years old; 2) Participants willing to undergo overnight polysomnography and sleep respiratory monitoring.
Exclusion criteria
Exclusion criteria: 1) Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction; 2) Participants with unstable respiratory diseases, or other diseases in acute phase; 3) Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep; 4) Participants that undergo CPAP treatment during the night of the trial; 5) Participants with other sleep disorders, e.g. insomnia; 6) Participants with mental disorders; 7) Participants that refuse to sign informed consents; 8) Participants unable to cooperate with medical examination; 9) Participants excluded by the investigator for reasons not listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of positive/negative results determined by AHI thresholds 5, 15 and 30, respectively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Agreement rate, kappa, ROCAUC of positive/negative results determined by AHI thresholds 5, 15 and 30, respectively;Apnea-Hypopnea Index, AHI;Total sleep time;Proportions of light/deep/REM sleep in total sleep time; | — |
Countries
China
Contacts
Public ContactYin, Shankai
Shanghai Sixth People's Hospital
Outcome results
None listed