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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | use the sleep pillow with the magnetic field modulation treatment |
|
| placebo group | Placebo Comparator | use the sleep pillow without magnetic field modulation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic field modulation device | Device | use the device with magnetic field modulation to treat insomnia |
|
| 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 |
| 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 |
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Inclusion Criteria:
1.18 to 65 years old. 2.Primary Insomnia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiong Ou, M.D. | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Genereal Hospital | Guangzhou | Guangdong | 510000 | China |
Previous research plan submitted to the Ethics Committee has stated the participant information not be shared
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| placebo device | Device | use the sleep pillow without magnetic field modulation treatment |
|
| 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 |
| D001523 |
| Mental Disorders |