Primary insomnia disorder
Conditions
Interventions
Treatment group(real stimualtion):The device (SDZ-IIB
Hwato, Suzhou, China) was used to stimulate the auricular cavum concha of the vagus nervewith the following parameters : (1) density waves adjusted to 20 Hz, with a wave width of 0.2 ms, (2) intensity
Control group(sham stimulation):The device (SDZ-IIB
Hwato, Suzhou, China) was used to stimulate the auricular cavum concha that without vagus nerve. The stimulation parameters is the same as treatment group.
Sponsors
Sichuan Provincial People's Hospital, School of Medicine,University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Patients ages ranged from 18 to 75 years old and right handed, male or female are accessible, who are experiencing these symptoms: difficulty in falling asleep, insufficient sleep time or difficulty in maintaining asleep state at least 3 months and occurring at least three times a week in accordance with the clinical diagnostic criteria for primary insomnia disorder in the "Chinese Classification and Diagnostic Criteria of Mental Disorders". Moreover, patients could experience fatigue during daytime, difficulty concentrating, and unstable emotions. (2)PSQI score >7, ISI score >14, 24-item HAMD <20, HAMD <21, Self-rating Anxiety Scale (SAS) standard score <69, Self-rating Depression Scale (SDS) standard score <72. (3)The symptoms that difficulty in falling asleep cannot be solely explained by factors, such as sleep environment (e.g., noise, light, comfort level); and there is no other neurological diseases could explain the cause of the insomnia. (4)The patient has not taken any sedative or sleeping medication within the past 1 month. (5)The patients have agreed to participate in this research and have junior middle school education level which can complete the tasks in our experiment. (6)The patients does not have any contraindication for magnetic resonance imaging,such as claustrophobia or metal implants. (patients must meet all the criteria above)
Exclusion criteria
Exclusion criteria: (1)Patients who are younger than 18 years old or older than 70 years old. (2)Patients with a history of head trauma or other neurological diseases, as well as other objective environmental reasons that can explain insomnia. (3)Patients have severe primary diseases in digestive system, hematopoietic system, endocrine system or tumors, and don’t have any contraindications for vagus nerve stimulation such as heart failure or thyroid disease. (4)PSQI score <7, ISI score <8, 24-item HAMD =20, HAMD =21, Self-rating Anxiety Scale (SAS) standard score =69, Self-rating Depression Scale (SDS) standard score = 72. (5)The patient has a history of drug abuse or alcoholism. (6)Patients have skin allergy, injury or inflammation in the concha and external auditory canal; (7) Patients are pregnant or preparing for pregnancy women or lactating women. (8)The patient has participated in other clinical trials in the past six months; or has taken anticholinergic drugs, sedative hypnotics, or hormone drugs within one month; or patents is taking prescribed drugs irregularly which may inhibit the activity of cerebral cortex or nervous system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Magnetic Resonance Imaging(fMRI);salivary cortisol;Heart rate variability(HRV);Pittsburgh Sleep Quality Index(PSQI);Insomnia Severity Index (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rating Anxiety Scale(SAS);Hamilton Anxiety Scale(HAMA);Self-rating depression scale(SDS); | — |
Countries
China
Contacts
Public ContactXiao Wu
Sichuan Provincial People's Hospital, School of Medicine,University of Electronic Science and Technology of China
Outcome results
None listed