A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in Anxiety Combined With Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705830
• Other study ID #: 2022-0704
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zheng Lin, Doctor
• Phone: 86-13757118261
• Email: Linzzr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Pulse magnetic therapy
Pulse magnetic therapy SM-II (2019102133903)

Drug:
• Selective serotonin reuptake inhibitors (SSRI)
Anti-anxiety Drugs

Device:
• Shame magnetic therapy
Shame magnetic therapy

Locations

Country	Name	City	State
China	Changxing County People's Hospita	Changxing	Zhejiang
China	Linping First People's Hospital	Linping	Zhejiang
China	The Fourth Affiliated Hospital of Zhejiang University School of medicine	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)	Insomnia Severity Index total score reduction>50%, the range of Insomnia Severity Index total score is 0-28.	Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention