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Study on the Therapeutic Effect of Propofol-Induced Sleep in Patients with Chronic Insomnia Accompanied by Anxiety and Depression: A Single-Arm Pilot Study

Study on the Therapeutic Effect of Propofol-Induced Sleep in Patients with Chronic Insomnia Accompanied by Anxiety and Depression: A Single-Arm Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123150
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Chronic insomnia accompanied by anxiety and/or depression

Interventions

Propofol Group :Propofol anesthesia induction sleep

Sponsors

Liaocheng People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chronic insomnia lasting more than 2 years, recurrent, and not improved after treatment with two or more different types of medications (treatment-resistant insomnia disorder, also known as refractory insomnia disorder), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. Age over 18 years, male or female; 3. Patients with moderate to severe insomnia, with insomnia severity index (ISI) >= 15; 4. Pittsburgh Sleep Quality Index (PSQI) total score > 7; 5. Accompanied by anxiety and/or depressive states: 14-item Hamilton Anxiety Scale (HAMA) >= 14; 24-item Hamilton Depression Scale (HAMD-24) >= 21; 6. Voluntarily participating in this treatment and having signed the clinical informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to propofol; 2. Those with cardiac conduction block, severe ventricular dysfunction, severe liver or kidney dysfunction, or other serious physical illnesses; 3. Those with abnormal blood pressure, bradycardia, or poorly controlled blood sugar in diabetes; 4. Those with sleep apnea before treatment; 5. Individuals with a history of head trauma; 6. Those with a history of epilepsy, psychiatric disorders, or abnormal EEG findings; 7. Individuals with a history of alcohol or drug abuse; those who are pregnant, breastfeeding, or planning pregnancy; 8. Those with MRI contraindications, including claustrophobia or metal implants in the body; 9. Individuals with an education level below elementary school or unable to understand the content of pre- and post-treatment assessment scales.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores before and after treatment;

Secondary

MeasureTime frame
Real-time EEG detection of changes in brain activity during propofol treatment in the prefrontal cortex;Nighttime raw EEG before and after treatment;Pittsburgh Sleep Quality Index score;

Countries

China

Contacts

Public ContactShi Fu

Liaocheng People's Hospital

317449197@qq.com+86 635 8271235

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026