Insomnia Disorder
Conditions
Interventions
2:sham-tVNS
1:transcutaneous vagus nerve stimulationt(tVNS) treatment
Sponsors
No.95 Tiankun 3rd Road Tianhe District Guangzhou China and The Second Clinical College of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnostic criteria: According to The Diagnostic and Statistical Manual of Mental Disorders V (SEM-V) the diagnostic criteria for insomnia disorders are as follows: 1) Significant dissatisfaction with the quality or quantity of sleep accompanied by at least one of the following symptoms: (1) Difficulty falling asleep; (2) difficulty maintaining sleep characterized by frequent awakenings or difficulty falling asleep after awakening; (3) inability to fall back asleep after waking early; 2) Sleep disturbance (or related daytime fatigue) causes significant distress or social occupational educational academic behavioral or other significant social impairment; 3) Sleep difficulties occur at least 3 times per week; 4) Sleep difficulties have been present for at least 3 months; 5) Sleep difficulties occur even if you have enough sleep opportunities; 6) Insomnia is not better explained by other sleep disorders and does not occur during the course of other sleep disorders (narcolepsy episodes breathing-related sleep disorders sleep-wake rhythm disorders and parasomnia); 7) Sleep is not caused by the physiological effects of substances (such as substance abuse); 8) Co-existing mental disorders and medical conditions are insufficient to explain significant sleep complaints. Inclusion criteria: 1) Meet the above diagnostic criteria; 2) The age range is 18 to 65 years old both male and female; (3) Pittsburgh Sleep Quality Index score > 7; 4) Have the ability to read and write and can cooperate with examination and treatment; 5) no acupuncture treatment for insomnia in the past 3 months; No metal implants no claustrophobia MRI and other contraindications; 6) Subjects are informed voluntarily accept tVNS treatment and sign informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Patients with serious life-threatening primary diseases such as cardiovascular and cerebrovascular liver kidney and hematopoietic system and other serious mental disorders; 2) Patients with severe Anxiety or Depression whose standard score is greater than or equal to 50 points by Self-Rating Anxiety Scale (SAS) or Self-rating Depression Scale (SDS); (3) Women who are pregnant or planning to become pregnant breastfeeding women; 4) insomnia caused by depression or anxiety disorder; Insomnia caused by poor sleep hygiene; Do not stop taking relevant drugs as required during treatment; 5) Patients who could not adhere to tVNS acupuncture treatment and could not understand the scale; Ear trauma (including sunburn cut infection and other lesions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale;Anxiety and Depression Scale;Epworth Sleepiness Scale; | — |
Countries
China
Contacts
Public ContactXin Chen
The Affiliated TCM Hospital of Guangzhou Medical University
Outcome results
None listed