Chronic insomnia combined with anxiety
Conditions
Interventions
Experimental Group:Stellate ganglion block + cognitive behavioral therapy for insomnia + dexmedetomidine hydrochloride nasal spray
Control group:Stellate ganglion block + cognitive behavioral therapy for insomnia + nasal spray with normal saline
Sponsors
Zibo Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 70 years old; (2) The diagnosis meets the diagnostic criteria for chronic insomnia in ICSD-3, with insomnia symptoms (difficulty falling asleep, sleep maintenance disorders, early awakening, decreased sleep quality and reduced total sleep time), and daytime functional impairment lasts for more than three months, combined with anxiety; (3) The scale screening meets the following requirements: (1)ISI>=14 points; (2)PSQI>=8 points; (3)GAD-7>=5 points; (4)PHQ-9 < 10 points; (4) Meet the conditions for compliance assessment and be able to cooperate with follow-up visits; (5) Have the ability to sign informed consent forms
Exclusion criteria
Exclusion criteria: (1) Other types of sleep disorders such as sleep apnea syndrome, restless legs syndrome, and parasomnia; (2) Those with abnormal nasal structure, rhinitis/epistaxis who are contraindicated for nasal spray administration, and those allergic to the drug components of dexmedetomidine hydrochloride nasal spray; (3) Severe or uncontrolled anxiety and depressive disorders, epilepsy; (4) Mental disorders such as schizophrenia, bipolar disorder, and personality disorder; (5) Oral anticoagulant drugs, coagulation dysfunction; (6) History of dysfunction of important organs, severe chronic lung disease, bradycardia, hypotension, cardiovascular instability or recent major surgical history; (7) Pregnant women, those who are breastfeeding or planning to become pregnant during the study period; (8) Other factors that affect drug metabolism or test results (such as severe liver or kidney dysfunction, alcohol or opioid drug dependence, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index(ISI);Pittsburgh Sleep Quality Index(PSQI);Generalized Anxiety Disorder(GAD-7); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep efficiency;Sleep latency;Interleukin-6; | — |
Countries
China
Contacts
Public ContactWu Xue
Zibo Central Hospital
Outcome results
None listed