Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Study Overview
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Brief Summary
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This interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment.

Detailed Description
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Patients with insomnia receiving this sleep pillow with magnetic system or not would be observed in months.The effect of sleep pillow with magnetic system for insomnia would evaluated.

Official Title
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Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Conditions
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Insomnia

Intervention / Treatment
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* Device: magnetic field modulation device
* Device: placebo device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 to 65 years old. 2.Primary Insomnia Exclusion Criteria: Secondary Insomnia Pilot, high-altitude operator Pregnant, lactating women Patients with serious disease The researchers believe that the candidates are not eligible

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>use the sleep pillow with the magnetic field modulation treatment | Device: magnetic field modulation device<br>* use the device with magnetic field modulation to treat insomnia<br>|
| Placebo Comparator: placebo group<br>use the sleep pillow without magnetic field modulation treatment | Device: placebo device<br>* use the sleep pillow without magnetic field modulation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | The Sleep Quality of Patients with insomnia as Reflected by PSQI scale.The PSQI scale, consisting of 18 self-rated items, was used to assess the subjects' sleep quality in the last month.The 18 self-rated items can be combined into seven factors: sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function.Each factor was scored on a scale of 0-3, and the total score of each factor was the total score of PSQI, with the total score ranging from 0-21. The higher the score was, the worse the sleep quality was | 5 weeks | 
| Insomnia severity index | The severity of insomnia was graded by ISI score，The total score of ISI was 8-14 for mild insomnia, 15-21 for moderate insomnia and 22 for severe insomnia. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of sleep diary | Some parameters of sleep diary | 5 weeks | 
| Response rate | The total score of Insomnia severity index (ISI) decreased by 50% compared with that before treatment or less than 9 points after treatment will be judged to be responsive. Total number of responsive subject after observation/total number of subject in the group*100%= response rate | 5 weeks | 
| Remission rate | The total score of Insomnia severity index (ISI) less than 9 points after treatment will be judged to be remissive. Total number of remissive subject after observation/total number of subject in the group*100%= remission rate | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Treatment, magnetic field modulation