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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05705830

Collaborator

(none)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

133.3

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Insomnia	Device: Pulse magnetic therapy Drug: Selective serotonin reuptake inhibitors （SSRI） Device: Shame magnetic therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulse Magnetotherapy+medication group 150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs	Device: Pulse magnetic therapy Pulse magnetic therapy SM-II (2019102133903) Drug: Selective serotonin reuptake inhibitors （SSRI） Anti-anxiety Drugs
Sham Comparator: medication group 150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs	Drug: Selective serotonin reuptake inhibitors （SSRI） Anti-anxiety Drugs Device: Shame magnetic therapy Shame magnetic therapy
Other: Healthy control 100 healthy controls who met the inclusion criteria received sham magnetic therapy	Device: Shame magnetic therapy Shame magnetic therapy

Arm

Intervention/Treatment

Experimental: Pulse Magnetotherapy+medication group

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

Device: Pulse magnetic therapy

Pulse magnetic therapy SM-II (2019102133903)

Drug: Selective serotonin reuptake inhibitors （SSRI）

Anti-anxiety Drugs

Sham Comparator: medication group

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

Drug: Selective serotonin reuptake inhibitors （SSRI）

Anti-anxiety Drugs

Device: Shame magnetic therapy

Shame magnetic therapy

Other: Healthy control

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

Device: Shame magnetic therapy

Shame magnetic therapy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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 besides drugs;
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 the brain);
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.

Contacts and Locations

Locations

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