sleep disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) 18-75 years old, gender not specified; (2) Experiences at least 3 nights of insomnia per week for at least 1 month, which meets the diagnostic criteria for transient insomnia disorder as stipulated in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition); (3) Has completed at least 9 years of formal education; (4) Has taken benzodiazepine or non-benzodiazepine sleeping pills for more than 4 weeks and is willing to reduce or stop taking the medication.
Exclusion criteria
Exclusion criteria: (1) Severe intestinal conditions (such as anal fissures, hemorrhoids, etc.) or a history of intestinal surgery (2) Severe coagulation disorders (3) Having an implanted pacemaker or other electronic implants (4) Having other mental health conditions (such as bipolar disorder, schizophrenia, obsessive-compulsive disorder) (5) Allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discontinuation of BZDs at the end of treatment, week 4, week 8, and week 12;Equivalent dose and weekly frequency of diazepam; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Pittsburgh Sleep Quality Index;Self-rating scale of somatization symptoms;BZDs Withdrawal Symptoms Questionnaire;Hamilton Anxiety and Depression Scale;Epworth Sleepiness Scale;Hospital Anxiety and Depression Scale;Functional near-infrared spectroscopy;Polysomnography; | — |
Countries
China
Contacts
The Fifth People's Hospital of Chengdu