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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Anxiety Disorder Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulse Magnetotherapy+medication group

150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs

Group Type EXPERIMENTAL

Pulse magnetic therapy

Intervention Type DEVICE

Pulse magnetic therapy SM-II (2019102133903)

Selective serotonin reuptake inhibitors （SSRI）

Intervention Type DRUG

Anti-anxiety Drugs

medication group

150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs

Group Type SHAM_COMPARATOR

Selective serotonin reuptake inhibitors （SSRI）

Intervention Type DRUG

Anti-anxiety Drugs

Shame magnetic therapy

Intervention Type DEVICE

Shame magnetic therapy

Healthy control

100 healthy controls who met the inclusion criteria received sham magnetic therapy

Group Type OTHER

Shame magnetic therapy

Intervention Type DEVICE

Shame magnetic therapy

Interventions

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Pulse magnetic therapy

Pulse magnetic therapy SM-II (2019102133903)

Intervention Type DEVICE

Selective serotonin reuptake inhibitors （SSRI）

Anti-anxiety Drugs

Intervention Type DRUG

Shame magnetic therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes