Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Insomnia Clinical Trial

Official title:

Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397472
• Other study ID #: GDREC2017326H(R1)
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2018
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• magnetic field modulation device
use the device with magnetic field modulation to treat insomnia
• placebo device
use the sleep pillow without magnetic field modulation treatment

Locations

Country	Name	City	State
China	Guangdong Genereal Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Parameters of sleep diary	Some parameters of sleep diary	5 weeks
Secondary	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
Secondary	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