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Effects of dexmedetomidine combined with propofol-induced sleep balance on sleep quality and structure in patients with chronic insomnia : A randomized controlled trial

Effects of dexmedetomidine combined with propofol-induced sleep balance on sleep quality and structure in patients with chronic insomnia : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109217
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Chronic insomnia

Interventions

Conventional treatment + anesthesia induction sleep balance group:Dexmedetomidine-Propofol Induced Sleep Regulation Therapy
Conventional treatment group:Conventional treatment

Sponsors

The First People's Hospital of Zunyi
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age above 18 years old, both males and females are eligible. 2.Meet the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 3.Total score of the Pittsburgh Sleep Quality Index (PSQI) > 7. 4.Voluntarily participate in the treatment and have signed the clinical informed consent form.

Exclusion criteria

Exclusion criteria: 1.Allergy to dexmedetomidine or propofol; 2.Presence of cardiac conduction block, severe ventricular dysfunction, severe hepatic or renal insufficiency, or other serious somatic diseases; 3.Abnormal blood pressure, bradycardia, or poorly controlled diabetes mellitus; 4.Detection of sleep apnea through polysomnography (PSG) conducted prior to treatment; 5.History of head trauma; 6.History of epilepsy, psychiatric disorders, or abnormal electroencephalogram (EEG) findings; 7.Known history of alcohol abuse or substance misuse; 8.Pregnancy, lactation, or planned pregnancy; 9.Educational level below elementary school or inability to comprehend the content of the rating scales used before and after treatment;

Design outcomes

Primary

MeasureTime frame
Structure of sleep;Quality of sleep;

Secondary

MeasureTime frame
Sleep diary;Adverse reactions;Hyperarousal condition;Vital signs;Blood biomarkers;Clinical efficacy;Patients' experience scores regarding the induction process;Anxiety and depression score;Multi-omics testing;

Countries

China

Contacts

Public ContactXiong LiuLin

The First People's Hospital of Zunyi

499465010@qq.com+86 851 28608507

Outcome results

None listed

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