NCT05705830

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety Disorder
• Insomnia

Interventions

Type	Name	Description
DEVICE	Pulse magnetic therapy	Pulse magnetic therapy SM-II (2019102133903)
DRUG	Selective serotonin reuptake inhibitors （SSRI）	Anti-anxiety Drugs
DEVICE	Shame magnetic therapy	Shame magnetic therapy

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2023-01-31
• Last updated: 2023-02-16

Locations

3 sites across 1 country: China