Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Device: magnetic field modulation device; Device: placebo device

• Registration Number: NCT03397472
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-12
• Study Start: 2018-01-18
• Status Verified: 2018-12
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	magnetic field modulation device	use the sleep pillow with the magnetic field modulation treatment
placebo group	placebo device	use the sleep pillow without magnetic field modulation treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangdong Genereal Hospital; 🇨🇳 Guangzhou, Guangdong, China