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Clinical Study on Early Risk Screening and Predictive Model of Perioperative Sleep Disorder (PSD)

Clinical Study on Early Risk Screening and Predictive Model of Perioperative Sleep Disorder (PSD)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126784
Enrollment
Unknown
Registered
2026-06-16
Start date
2026-06-19
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Insomnia

Interventions

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 64 years old (inclusive) 2. American Society of Anesthesiologists (ASA) physical status classification I–III 3. Patients scheduled for elective surgery under general anesthesia with an expected hospital stay of no less than 7 days 4. Possess basic reading and writing skills 5. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Preoperatively diagnosed sleep disorders including sleep apnea, chronic insomnia, etc. 2. History of severe neuropsychiatric diseases or long-term use of psychotropic drugs 3. Pregnant and lactating women 4. Patients requiring mechanical ventilation in ICU for more than 48 hours after surgery 5. Patients receiving continuous postoperative sedation 6. Participation in other interventional clinical trials 7. Subjects unable to complete assessments due to communication disorders.

Design outcomes

Primary

MeasureTime frame
Area Under the ROC Curve;Incidence status (positive/negative) and subtype classification of perioperative sleep disturbance (PSD) on postoperative days 5–7;

Secondary

MeasureTime frame
Overall incidence of PSD and constituent ratios of its subtypes on postoperative days 5 to 7;Fitbit monitoring indicators;PSQI scores and recurrence/persistence rates of sleep disorders at one month postoperatively;

Countries

China

Contacts

Public ContactYanjia Luo

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

lyj1988my@163.com+86 21 6305 7795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026