Insomnia
Conditions
Keywords
Insomnia, Treatment, magnetic field modulation
Brief summary
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
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.
Interventions
DEVICEmagnetic field modulation device
use the device with magnetic field modulation to treat insomnia
DEVICEplacebo device
use the sleep pillow without magnetic field modulation treatment
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1.18 to 65 years old. 2.Primary Insomnia
Exclusion criteria
1. Secondary Insomnia 2. Pilot, high-altitude operator 3. Pregnant, lactating women 4. Patients with serious disease 5. The researchers believe that the candidates are not eligible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | 5 weeks | 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 |
| Insomnia severity index | 5 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameters of sleep diary | 5 weeks | Some parameters of sleep diary |
| Response rate | 5 weeks | 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 |
| Remission rate | 5 weeks | 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 |
Countries
China
Outcome results
None listed