Skip to content

To evaluate the effect and mechanism of brain-gut-bacterial axis of anesthesia in insomnia disorder based on multimodal imaging

To evaluate the effect and mechanism of brain-gut-bacterial axis of anesthesia in insomnia disorder based on multimodal imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095164
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-20
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

Insomnia Disorder, ID

Interventions

Dex nasal spray treatment group:Dexmedetomidine nasal spray treatment
SGB treatment group:Stellate ganglion block therapy
Dex nasal spray + SGB combined treatment group:Combined dexmedetomidine nasal spray and stellate ganglion block therapy

Sponsors

Henan Provincial People's Hospita,medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Met the diagnostic criteria for ID and had repeated episodes that could not be alleviated by medication, physiotherapy or cognitive behavioral therapy; 2. Meet the dual criteria of subjective scale and objective PSG diagnostic ID, and the scale score requires PSQI>=7 points; 3. Age 18-60 years old; 4. Primary school education or above; 5. MRI routine brain examination was normal; 6. Right-handed.

Exclusion criteria

Exclusion criteria: 1. Insomnia caused by sleep disorders, such as obstructive sleep apnea syndrome, sleep periodic limb movement, etc; 2. Severe suicidal ideation, severe mental disorder; 3. Have or currently have a history of tobacco, alcohol and drug abuse; 4. bradycardiac arrhythmia; 5. Pregnancy; 6. Taking antibiotics for more than 3 days within 1 month; 7. MRI contraindications; 8. Claustrophobia; 9. History of mental and neurological diseases and head trauma; 10. Hereditary diseases in the family; 11. History of major physical illness; 12. Severe rhinitis, nasal deformity; 13. People who are allergic to narcotic drugs such as dexmedetomidine, midazolam or lidocaine;

Design outcomes

Primary

MeasureTime frame
Calculation and Statistical Analysis of Brain Function Indicators for Resting State Data;Sleep efficiency and sleep composition;Subjective sleep status;

Secondary

MeasureTime frame
Liver function, kidney function;5-hydroxytryptamine (5-HT), gamma aminobutyric acid (GABA), norepinephrine (NA), dopamine (DA);

Countries

China

Contacts

Public ContactYongli Li

Henan Provincial People's Hospita,medical

shyliyongli@126.com+86 371 65580759

Outcome results

None listed

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