Insomnia Disorder
Conditions
Interventions
Experimental Group:pulse magnetic therapy system (model: SM-II) produced by the BestCare&SuMian BioTech Co., Ltd.
Control Group:Same instrument without output
Sponsors
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 65 years; 2. Meeting DSM-5 diagnostic criteria for insomnia disorder: (1) Complaint of dissatisfaction with the quantity or quality of sleep, accompanied by one or more of the following symptoms: ? Difficulty in falling asleep; ? Difficulty in maintaining sleep, characterized by frequent awakening or difficulty in falling asleep after awakening; ? Wake up early but not fall asleep again; (2) The sleep disorder causes clinically significant distress or causes impairment to social, vocational, educational, academic, behavioral or other important functions; (3) Sleep difficulties occur at least three nights a week; (4) Sleep difficulties at least 3 months; (5) Despite adequate sleep opportunities, sleep difficulties still occur; (6) Insomnia cannot be better explained by other sleep-wakefulness disorders, nor can it only occur in other sleep-wakefulness disorders (e.g., narcolepsy, respiratory-related sleep disorders, circadian rhythm sleep-wakefulness disorders, abnormal sleep); (7) Insomnia cannot be attributed to the physiological effects of certain substances (e.g. abused drugs or drugs). (8) The complaints of insomnia cannot fully explained by the coexistence of mental disorders and physical disorders. 3. Insomnia severity index (ISI) scale score > 9 points. 4. Know and consent, sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Insomnia associated with other mental disorders,sleep disorders caused by medical diseases and substances;Poor sleep hygiene,environmental sleep disorder, Jet lag syndrome, shift work sleep disorder, untreated sleep apnea syndrome(PSG examination found AHI > 15/hour), or periodic limb movements during sleep (PLMSI > 15/hour); People with moderate to severe anxiety and/or depressive symptoms(GAD-7>9 and/or PHQ-9 > 9); 2. Professional drivers or aerial operators; 3. Pregnant or lactating women; 4. Having History of serious primary heart, liver, kidney and blood system diseases ; 5. Having History of epileptic seizures or family history of strongly positive epilepsy; 6. Implanted Pacemaker; 7. Receiving deep brain stimulation therapy; 8. Implanted magnetic or metal in the body(including but not limited to the brain); 9. Participated in clinical trials of other drugs and medical devices in the past three months; 10. Other conditions considered as not eligible for selection by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Insomnia Severity Index ; | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate and remission rate of insomnia disorder;Average Sleep Latency;Sleep Efficiency;Actual Sleep Time;wake after sleep onset ;Changes of Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactJiyan Pan, MD
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Outcome results
None listed