Magnetic Field Modulation Pillow for Insomnia Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Device: magnetic field modulation device; Device: placebo device

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Genereal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; use the sleep pillow with the magnetic field modulation treatment	Device: magnetic field modulation device; use the device with magnetic field modulation to treat insomnia
Placebo Comparator: placebo group; use the sleep pillow without magnetic field modulation treatment	Device: placebo device; use the sleep pillow without magnetic field modulation treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Qiong Ou, M.D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Treatment; Insomnia; magnetic field modulation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: GDREC2017326H(R1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Previous research plan submitted to the Ethics Committee has stated the participant information not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No