NCT05705830

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. 1.Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients.
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 16, 2023

Status Verified

October 1, 2022

Enrollment Period

3.1 years

First QC Date

October 25, 2022

Last Update Submit

February 15, 2023

Conditions

Anxiety DisorderInsomnia

Keywords

AnxietyInsomniaPulse Magnetotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Pulse Magnetotherapy+medication group

EXPERIMENTAL

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

Device: Pulse magnetic therapyDrug: Selective serotonin reuptake inhibitors （SSRI）

medication group

SHAM COMPARATOR

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）Device: Shame magnetic therapy

Healthy control

OTHER

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

Device: Shame magnetic therapy

Interventions

Pulse magnetic therapyDEVICE

Pulse magnetic therapy SM-II (2019102133903)

Pulse Magnetotherapy+medication group
Selective serotonin reuptake inhibitors （SSRI）DRUG

Anti-anxiety Drugs

Pulse Magnetotherapy+medication groupmedication group
Shame magnetic therapyDEVICE

Shame magnetic therapy

Healthy controlmedication group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Changxing County People's Hospita

Changxing, Zhejiang, China

RECRUITING

Linping First People's Hospital

Linping, Zhejiang, China

RECRUITING

The Fourth Affiliated Hospital of Zhejiang University School of medicine

Yiwu, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Mental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Study Officials

  • Zheng Lin

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Lin, Doctor

CONTACT

86-13757118261Linzzr@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

January 31, 2023

Study Start

November 1, 2022

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

February 16, 2023

Record last verified: 2022-10

Locations

CN(3)