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Effect of closed-loop auditory stimulation enhancing slow oscillations on sleep quality after general anesthesia

Effect of closed-loop auditory stimulation enhancing slow oscillations on sleep quality after general anesthesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095128
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Postoperative sleep disorders

Interventions

Experimental group:closed-loop auditory stimulation
Control group:blank stimulation

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years old; 2. American Society of Anesthesiologists grade I to III; 3. Patients undergoing elective non-cardiac and non-neurosurgical procedures; 4. Postoperative hospital stay > 3 days; 5. The MMSE score is higher than the minimum score of the corresponding cultural level: the level of primary school (6 years by education is = 20 points, middle school and above cultural level (6 years of education) >= 23 points. 6.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Perioperative sleep disorder, preoperative PSQI score > 7; 2. Combined with sleep disorders, such as obstructive sleep apnea syndrome and narcolepsy; 3. Hearing, vision, and speech barriers; 4. Long-term use of antidepressants or psychotropic drugs; 5. Nervous system disease or mental illness, serious systemic diseases; 6. Patients with severe complications such as bleeding, cerebral infarction, pulmonary infection after surgery and secondary surgery.

Design outcomes

Primary

MeasureTime frame
Postoperative sleep quality;

Secondary

MeasureTime frame
Pain score;Postoperative cognitive dysfunction, POCD;Postoperative adverse reactions;EEG;Pittsburgh sleep disturbance index (PSQI);Income ratio, adherence;Night sleep conditions, including total sleep time, sleep efficiency, sleep latency, etc;

Countries

China

Contacts

Public ContactJianhui Liu

Shanghai Tongji Hospital

jianhuiliu_1246@163.com+86 136 6145 2939

Outcome results

None listed

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