Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
NCT ID: NCT06252779
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-01
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Plasma stimulation therapy group
Plasma 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.
False stimulation treatment group
Fake 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.
Interventions
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Plasma 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.
Fake 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
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Qinying Ma
OTHER
Responsible Party
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Qinying Ma
chief physician
Locations
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Qinying Ma
Shijiazhuang, , China
Countries
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Central Contacts
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Facility Contacts
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Qinying Ma
Role: primary
Other Identifiers
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20221117
Identifier Type: -
Identifier Source: org_study_id