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

Phase

N/A

Condition

Insomnia

Panic Disorders

Stress

Treatment

N/A

Clinical Study ID

NCT05705830

2022-0704

Ages 18-55
All Genders
Accepts Healthy Volunteers

Study 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:

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients who met the diagnostic criteria for anxiety disorder in the Diagnostic andStatistical Manual of Mental Disorders (Fifth edition; DSM-5) and were accompanied byinsomnia with 14 <HAMA<21 , HAMD<17 , and PSQI>7 ;
Education level is unlimited;
Age: 18-55 years old.

Exclusion

Exclusion Criteria:

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 besidesdrugs;
Pregnant and lactating women;
Have a history of seizures or strong positive family history of epilepsy;
Implantation of cardiac pacemaker;
Those receiving deep brain stimulation treatment;
There are metal or magnetic implants in the body (including but not limited to thebrain);
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.

Study Design

November 01, 2022

December 31, 2025

Study 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.

Connect with a study center

Changxing County People's Hospita
Changxing, Zhejiang
China
Active - Recruiting
Linping First People's Hospital
Linping, Zhejiang
China
Active - Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of medicine
Yiwu, Zhejiang
China
Active - Recruiting

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