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

Not Applicable

Recruiting

• Conditions: Insomnia; Anxiety Disorder
• Interventions: Drug: Selective serotonin reuptake inhibitors （SSRI）; Device: Pulse magnetic therapy; Device: Shame magnetic therapy

• Registration Number: NCT05705830
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study Start: 2022-11-01
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-01-31
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medication group	Selective serotonin reuptake inhibitors （SSRI）	150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs
Pulse Magnetotherapy+medication group	Pulse magnetic therapy	150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs
Pulse Magnetotherapy+medication group	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	Shame magnetic therapy	150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs
Healthy control	Shame magnetic therapy	100 healthy controls who met the inclusion criteria received sham magnetic therapy

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	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.

Trial Locations

Locations (3)

Linping First People's Hospital; 🇨🇳 Linping, Zhejiang, China

The Fourth Affiliated Hospital of Zhejiang University School of medicine; 🇨🇳 Yiwu, Zhejiang, China

Changxing County People's Hospita; 🇨🇳 Changxing, Zhejiang, China