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Validation Study of a Wireless Sleep Monitoring System

Validation Study of a Wireless Sleep Monitoring System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070404
Enrollment
Unknown
Registered
2023-04-11
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

sleep disorders

Interventions

case series:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have been confirmed to need PSG monitoring by the sleep clinic and can complete the monitoring in the sleep center should be aged 18-80 years, no gender limit; 2. Agree and cooperate to complete the monitoring required for the study; 3. Patients can sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. The size of the ring is not appropriate for patients, and the ring cannot be worn; 2. Other circumstances that may affect the research objectives or the researcher thinks may affect the research conclusions.

Design outcomes

Primary

MeasureTime frame
Apnea hypopnea index;

Secondary

MeasureTime frame
Number of obstructive apneas;Number of mixed apneas;Number of central apneas;Maximum duration of respiratory events;Mean oxygen saturation during sleep;Minimum oxygen saturation during sleep;Oxygen desaturation index;Cumulative time at SpO2<90%;Average heart rate during sleep;Highest and lowest heart rate during sleep;Highest and lowest heart rate during recording;Total sleep time;Percent sleep efficiency;Sleep latency;Stage R latency;Wake after sleep onset;Time in each stage;Percent of TST in each stage (time in each stage/TST)x100;

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