Pulse magnetotherapy combined with medication for anxiety and insomnia

A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in the Treatment of Patients With Anxiety Disorder and Insomnia

This study is testing if combining pulse magnetic therapy with medication can help people with anxiety and insomnia sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 3 sites (Changxing, Zhejiang and 2 other locations)
• Trial ID: NCT05705830 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of pulse magnetic therapy combined with medication in treating patients suffering from anxiety and insomnia. It involves a multicenter randomized controlled design with three groups: one receiving pulse magnetic stimulation with drug treatment, another receiving sham stimulation with drug treatment, and a healthy control group. Participants will undergo comprehensive evaluations using various scales before and after treatment to assess improvements in their symptoms. The study aims to determine if pulse magnetic therapy can significantly enhance sleep quality in anxiety patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 who meet the diagnostic criteria for anxiety disorder with accompanying insomnia.

Not a fit: Patients with other significant mental health disorders or serious medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients struggling with anxiety and insomnia.

How similar studies have performed: While pulse magnetic therapy is gaining attention, this specific combination with medication in treating anxiety and insomnia is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. 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 ;
2. Education level is unlimited;
3. Age: 18-55 years old.

Exclusion Criteria:

1. Have bipolar disorder, schizophrenia, depression and other mental diseases;
2. Have a clear history of head trauma, alcoholism, brain tumors, diabetes, hypertension, and serious primary heart, liver, kidney, and blood system diseases;
3. At present, patients with sleep disorders are being treated by other means besides drugs;
4. Pregnant and lactating women;
5. Have a history of seizures or strong positive family history of epilepsy;
6. Implantation of cardiac pacemaker;
7. Those receiving deep brain stimulation treatment;
8. There are metal or magnetic implants in the body (including but not limited to the brain);
9. Participated in clinical trials of other drugs and medical devices in recent 3 months;
10. Other researchers believe that they do not meet the conditions for inclusion.

Where this trial is running

Changxing, Zhejiang and 2 other locations

• Changxing County People's Hospita — Changxing, Zhejiang, China (Recruiting)
• Linping First People's Hospital — Linping, Zhejiang, China (Recruiting)
• The Fourth Affiliated Hospital of Zhejiang University School of medicine — Yiwu, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Zheng Lin — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Zheng Lin, Doctor

Conditions Anxiety Disorder; Insomnia; Anxiety; Pulse Magnetotherapy