Chronic Insomnia Disorder
Conditions
Brief summary
This study is a single center study, led by Dr. Ma Qinying from the Department of Neurology at the First Hospital of Hebei Medical University. This study is an intervention study on plasma stimulation, involving patients with insomnia disorders to observe the effectiveness of plasma stimulation on insomnia disorders. Collect the Hamilton Anxiety Scale, Hamilton Depression Scale, Pittsburgh Sleep Quality Index Scale, Insomnia Severity Index Scale, and Somatization Symptom Self Rating Scale from patients before and after intervention. Transcranial magnetic stimulation synchronous electroencephalogram (TMS-EEG) and functional magnetic resonance imaging data. The research period is from December 2023 to July 2025, and a total of 40 patients are planned to be included in the study.
Interventions
DEVICEPlasma therapy equipment
The host of this product contains a high-voltage generator that can generate high-voltage electrical energy and deliver it to the treatment head. The air supply mechanism sends air to the ionization chamber inside the treatment head, which is ionized under the action of high-voltage electricity to generate thermal plasma, forming a particle flow mainly composed of active nitric oxide (pNO), which is then sprayed out from the nozzle of the treatment head to the target tissue of the human body. PNO particles can alter skin permeability, allowing them to act on specific parts of the body after transdermal absorption on the surface of the body.The patient will receive 14 days of treatment, with 20 minutes per day.
DEVICEFake therapeutic device
False stimuli with the same appearance and pattern as Plasma therapy equipment.The patient will receive 14 days of treatment, with 20 minutes per day.
Sponsors
Qinying Ma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-75 years old, gender is not limited; 2. right-handed; 3. the audiovisual level is sufficient to complete the examinations required for the study; 4. No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect; 5. Informed consent signed by the patient or family member.
Exclusion criteria
1. Substance abuse/dependence within 6 months prior to enrollment; 2. Have had other mental illnesses within 6 months prior to enrollment; 3. Those with severe or unstable organic diseases; 4. pregnant or lactating women; 5. Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3; 6. Those who have participated in any other clinical trials within 1 month before enrollment; 7. In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional magnetic resonance imaging | Before and after 14 day/false stimulation, 20 minutes each time | Functional magnetic resonance imaging (fMRI) is an imaging technique based on blood oxygen level dependence (BOLD), which can display small changes in magnetic resonance signals caused by changes in blood oxygenation status in venous capillaries in various regions of the brain. |
| Transcranial Magnetic Stimulation Combined Electroencephalography | Before and after 14 day/false stimulation, 20 minutes each time | with the advancement of technology, magnetic compatible EEG electrodes and amplifiers have been invented, making it possible to synchronously record undisturbed EEG under transcranial magnetic stimulation. The monitoring technology of transcranial magnetic stimulation combined electroencephalography (TMS-EEG) has also emerged |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Scale | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation | Neurological examination scale for evaluating the anxiety status of subjects in the past month |
| Insomnia Severity Index Scale | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation | ISI includes 7 questions that assess the severity and impact of insomnia, as well as its impact on daily function and psychological state. |
| Somatization Symptom Self Rating Scale | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation | This scale can effectively assist non psychotherapists in identifying physical symptom disorders in a timely and early manner |
| Hamilton Depression Scale | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation | Neurological examination scale for evaluating the depression status of subjects in the past month |
| Pittsburgh Sleep Quality Index Scale | Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation | PSQI was developed by Pittsburgh psychiatrist Buysse in the United States to evaluate the sleep quality of participants in the past month. It is suitable for evaluating the sleep quality of patients with sleep disorders and mental disorders, as well as for evaluating the sleep quality of the general population |
Countries
China
Contacts
Primary ContactQinying Ma
Outcome results
None listed