Chronic Insomnia DisorderNCT06252779
Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
A study testing Plasma therapy equipment and Fake therapeutic device in people with Chronic Insomnia Disorder, run by Qinying Ma at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia Disorder
- What is being tested?
- Plasma therapy equipment and Fake therapeutic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender is not limited;
- right-handed;
- the audiovisual level is sufficient to complete the examinations required for the study;
- No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect;
- Informed consent signed by the patient or family member.
Who cannot join
- Substance abuse/dependence within 6 months prior to enrollment;
- Have had other mental illnesses within 6 months prior to enrollment;
- Those with severe or unstable organic diseases;
- pregnant or lactating women;
- Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3;
- Those who have participated in any other clinical trials within 1 month before enrollment;
- In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qinying Ma
Shijiazhuang
Qinying Ma, 18633889488, qinyingma1921@hebmu.edu.cn
About this study
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.
- Conditions
- Chronic Insomnia Disorder
- Being tested
- Plasma therapy equipment, Fake therapeutic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma therapy equipmentDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Plasma stimulation therapy group | Experimental | Not described Receives: Device: Plasma therapy equipment |
| False stimulation treatment group | Placebo comparator | Not described Receives: Device: Fake therapeutic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging
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.
Measured: Before and after 14 day/false stimulation, 20 minutes each time
Transcranial Magnetic Stimulation Combined Electroencephalography
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
Measured: Before and after 14 day/false stimulation, 20 minutes each time
Secondary outcomes (5)
Insomnia Severity Index Scale
ISI includes 7 questions that assess the severity and impact of insomnia, as well as its impact on daily function and psychological state.
Measured: 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
Pittsburgh Sleep Quality Index Scale
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
Measured: 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
Hamilton Anxiety Scale
Neurological examination scale for evaluating the anxiety status of subjects in the past month
Measured: 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
Hamilton Depression Scale
Neurological examination scale for evaluating the depression status of subjects in the past month
Measured: 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
Somatization Symptom Self Rating Scale
This scale can effectively assist non psychotherapists in identifying physical symptom disorders in a timely and early manner
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinying Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qinying Ma, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252779
- Sponsor's protocol ID
- 20221117
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
- ClinicalTrials.gov ID
- NCT06252779
- Acronym / sponsor ID
- 20221117
- Conditions
- Chronic Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qinying MaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma stimulation therapy group | Experimental | Device: Plasma therapy equipment |
| False stimulation treatment group | Placebo comparator | Device: Fake therapeutic device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years old, gender is not limited;
- right-handed;
- the audiovisual level is sufficient to complete the examinations required for the study;
- No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect;
- Informed consent signed by the patient or family member.
Key exclusion criteria (7 listed)
- Substance abuse/dependence within 6 months prior to enrollment;
- Have had other mental illnesses within 6 months prior to enrollment;
- Those with severe or unstable organic diseases;
- pregnant or lactating women;
- Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma therapy equipmentThe 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. | Device | Plasma stimulation therapy group |
| Fake therapeutic deviceFalse stimuli with the same appearance and pattern as Plasma therapy equipment.The patient will receive 14 days of treatment, with 20 minutes per day. | Device | False stimulation treatment group |
Primary outcome
Functional magnetic resonance imaging
Time frame: 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
Time frame: 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
5 secondary outcomes
Insomnia Severity Index Scale
Time frame: 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
Pittsburgh Sleep Quality Index Scale
Time frame: 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
Hamilton Anxiety Scale
Time frame: 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
Hamilton Depression Scale
Time frame: 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
Somatization Symptom Self Rating Scale
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma therapy equipment and Fake therapeutic device in people with Chronic Insomnia Disorder, run by Qinying Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinying Ma (18633889488, qinyingma1921@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional magnetic resonance imaging (time frame: Before and after 14 day/false stimulation, 20 minutes each time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.