Anxiety DisorderNCT05705830
A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in Anxiety Combined With Insomnia
A study testing Pulse magnetic therapy and Selective serotonin reuptake inhibitors （SSRI） in people with Anxiety Disorder and Insomnia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are: 1. Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Insomnia
- What is being tested?
- Pulse magnetic therapy and Selective serotonin reuptake inhibitors （SSRI）
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2022to 31 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who met the diagnostic criteria for anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth edition; DSM-5) and were accompanied by insomnia with 14 <HAMA<21 , HAMD<17 , and PSQI>7 ;
- Education level is unlimited;
- Age: 18-55 years old.
Who cannot join
- Have bipolar disorder, schizophrenia, depression and other mental diseases;
- Have a clear history of head trauma, alcoholism, brain tumors, diabetes, hypertension, and serious primary heart, liver, kidney, and blood system diseases;
- At present, patients with sleep disorders are being treated by other means besides drugs;
- Pregnant and lactating women;
- Have a history of seizures or strong positive family history of epilepsy;
- Implantation of cardiac pacemaker;
Show all 10Show fewer
- Those receiving deep brain stimulation treatment;
- There are metal or magnetic implants in the body (including but not limited to the brain);
- Participated in clinical trials of other drugs and medical devices in recent 3 months;
- Other researchers believe that they do not meet the conditions for inclusion.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Changxing County People's Hospita
Changxing, Zhejiang
Tao Yan, Master, 86-13957258775
- Recruiting
Linping First People's Hospital
Linping, Zhejiang
Yuze Sheng, Master, 86-15990077882
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of medicine
Yiwu, Zhejiang
Yunrong Lu, Doctor, 86-13757118257
About this study
Official title: A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in the Treatment of Patients With Anxiety Disorder and Insomnia
The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are:
- Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients.
- This improvement is not due to the placement of the instrument。 Participants will accept pulse magnetic therapy (stimulation/sham stimulation) and accept scale evaluation before and after treatment.
Researchers will compare the pulse magnetic stimulation group, sham stimulation group and healthy controls to see if the pulse magnetic stimulation do effect on insomnia of anxiety patients.
Read the detailed description
Insomnia is the most common symptom of anxiety disorder, which has an important impact on the prognosis of anxiety. Pulse magnetic therapy system, with its advantages of compact, convenient, easy to carry, and not limited by the scene and time, has gradually become a common tool for sleep monitoring and treatment. This study is a multicenter randomized controlled design, including 150 cases in the pulse magnetic stimulation+drug treatment group, 150 cases in the sham pulse magnetic stimulation+drug treatment group and 100 healthy controls. Before and after treatment, the patients were comprehensively measured and evaluated with Insomnia Severity Index (ISI), Hamilton Depression Rating Scale 17 (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Sleep Scale (SSRS), Self-Rating Symptom Scale 90 (SCL-90), Quality of Life Scale (SF-36), and Treatment Adverse Reaction Scale (TESS), and sleep monitoring was conducted at the same time, To explore the therapeutic effect of pulse magnetic therapy system detector combined with drug therapy on patients with anxiety and insomnia.
- Conditions
- Anxiety Disorder, Insomnia
- Being tested
- Pulse magnetic therapy, Selective serotonin reuptake inhibitors （SSRI）, Shame magnetic therapy
- Keywords
- Anxiety, Insomnia, Pulse Magnetotherapy
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse magnetic therapyDevice
Pulse magnetic therapy SM-II (2019102133903)
Selective serotonin reuptake inhibitors （SSRI）Drug
Anti-anxiety Drugs
Shame magnetic therapyDevice
Shame magnetic therapy
| Study group | Role | What they receive |
|---|---|---|
| Pulse Magnetotherapy+medication group | Experimental | 150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs Receives: Device: Pulse magnetic therapy; Drug: Selective serotonin reuptake inhibitors （SSRI） |
| medication group | Sham comparator | 150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs Receives: Drug: Selective serotonin reuptake inhibitors （SSRI）; Device: Shame magnetic therapy |
| Healthy control | Other | 100 healthy controls who met the inclusion criteria received sham magnetic therapy Receives: Device: Shame magnetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Insomnia Severity Index total score reduction>50%, the range of Insomnia Severity Index total score is 0-28.
Measured: Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng Lin, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705830
- Sponsor's protocol ID
- 2022-0704
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in the Treatment of Patients With Anxiety Disorder and Insomnia
- ClinicalTrials.gov ID
- NCT05705830
- Acronym / sponsor ID
- 2022-0704
- Conditions
- Anxiety Disorder, Insomnia
- Keywords
- Anxiety, Insomnia, Pulse Magnetotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2023 (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.
The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are:
- Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients.
- This improvement is not due to the placement of the instrument。 Participants will accept pulse magnetic therapy (stimulation/sham stimulation) and accept scale evaluation before and after treatment.
Researchers will compare the pulse magnetic stimulation group, sham stimulation group and healthy controls to see if the pulse magnetic stimulation do effect on insomnia of anxiety patients.
Detailed description
Insomnia is the most common symptom of anxiety disorder, which has an important impact on the prognosis of anxiety. Pulse magnetic therapy system, with its advantages of compact, convenient, easy to carry, and not limited by the scene and time, has gradually become a common tool for sleep monitoring and treatment. This study is a multicenter randomized controlled design, including 150 cases in the pulse magnetic stimulation+drug treatment group, 150 cases in the sham pulse magnetic stimulation+drug treatment group and 100 healthy controls. Before and after treatment, the patients were comprehensively measured and evaluated with Insomnia Severity Index (ISI), Hamilton Depression Rating Scale 17 (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Sleep Scale (SSRS), Self-Rating Symptom Scale 90 (SCL-90), Quality of Life Scale (SF-36), and Treatment Adverse Reaction Scale (TESS), and sleep monitoring was conducted at the same time, To explore the therapeutic effect of pulse magnetic therapy system detector combined with drug therapy on patients with anxiety and insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulse Magnetotherapy+medication group | Experimental | Device: Pulse magnetic therapy, Drug: Selective serotonin reuptake inhibitors （SSRI）150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs |
| medication group | Sham comparator | Drug: Selective serotonin reuptake inhibitors （SSRI）, Device: Shame magnetic therapy150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs |
| Healthy control | Other | Device: Shame magnetic therapy100 healthy controls who met the inclusion criteria received sham magnetic therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who met the diagnostic criteria for anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth edition; DSM-5) and were accompanied by insomnia with 14 <HAMA<21 , HAMD<17 , and PSQI>7 ;
- Education level is unlimited;
- Age: 18-55 years old.
Key exclusion criteria (10 listed)
- Have bipolar disorder, schizophrenia, depression and other mental diseases;
- Have a clear history of head trauma, alcoholism, brain tumors, diabetes, hypertension, and serious primary heart, liver, kidney, and blood system diseases;
- At present, patients with sleep disorders are being treated by other means besides drugs;
- Pregnant and lactating women;
- Have a history of seizures or strong positive family history of epilepsy;
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 |
|---|---|---|
| Pulse magnetic therapyPulse magnetic therapy SM-II (2019102133903) | Device | Pulse Magnetotherapy+medication group |
| Selective serotonin reuptake inhibitors （SSRI）Anti-anxiety Drugs | Drug | Pulse Magnetotherapy+medication group, medication group |
| Shame magnetic therapyShame magnetic therapy | Device | Healthy control, medication group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention
Insomnia Severity Index total score reduction>50%, the range of Insomnia Severity Index total score is 0-28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Related trials for Anxiety Disorder
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
Zheng Lin principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse magnetic therapy and Selective serotonin reuptake inhibitors （SSRI） in people with Anxiety Disorder and Insomnia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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 3 inclusion and 10 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Zheng Lin, Doctor (86-13757118261, Linzzr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention). 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 16 Feb 2023.