Primary insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the criteria for insomnia disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic criteria; 2) Persistent insomnia symptoms for more than 3 months, occurring =3 times per week; 3) Aged 18-70, right-handed; 4) Pittsburgh Sleep Quality Index (PSQI) scale score =8 points, Hamilton Depression Scale The score on the scale is =17 and the score on the Hamilton Anxiety Scale is =14; 5) I have not taken any drugs or substances that act on the nervous system in the past month, nor have I undergone any undergo acupuncture and moxibustion treatment; 6) Able to undergo buccal needle therapy and cooperate in the acquisition of magnetic resonance data; 7) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with severe comorbidities, such as coronary heart disease, malignant tumors, renal failure, etc; 2) Patients with concomitant cerebral organic diseases; 3) History of epileptic seizures 4) Co-existing with any other mental disorders (including moderate to severe anxiety and depression), personality disorders, or Individuals with abuse or dependence on psychoactive substances; 5) Those who cannot be eluted by drugs are treated with drugs or acupuncture and moxibustion; 6) Pregnant and lactating women; 7) Having contraindications for MRI examination; 8) Work as a night shift worker 9) Previous exposure to electroconvulsive therapy, transcranial magnetic stimulation, or transcranial direct current stimulation 10) Other sleep disorders exist, including sleep apnea, periodic limb movements, and sleep Abnormality, lethargy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collect PSQI scores before treatment, at 4 weeks, 8 weeks, 12 weeks, and 20 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Various assessment scales, including ISI, HAMD, HAMA, ESS, FSS, and AIS, were collected before treatment, at 4 weeks, 8 weeks, 12 weeks, and 20 weeks;Before and during treatment Vital signs;The activity level of various regions in the brain at rest and within 48 hours after the 8th week of treatment fMRI data;Secondary outcomes included mental health, sleepiness and fatigue, as well as safety; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Dalian Medical University