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Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnetic field modulation device
placebo device
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Treatment, magnetic field modulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Genereal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment group

placebo group

Arm Description

use the sleep pillow with the magnetic field modulation treatment

use the sleep pillow without magnetic field modulation treatment

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Parameters of sleep diary
Some parameters of sleep diary
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
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

Full Information

First Posted
January 4, 2018
Last Updated
March 24, 2020
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03397472
Brief Title
Magnetic Field Modulation Pillow for Insomnia Clinical Trial
Official Title
Magnetic Field Modulation Pillow for Insomnia Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Treatment, magnetic field modulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
use the sleep pillow with the magnetic field modulation treatment
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
use the sleep pillow without magnetic field modulation treatment
Intervention Type
Device
Intervention Name(s)
magnetic field modulation device
Intervention Description
use the device with magnetic field modulation to treat insomnia
Intervention Type
Device
Intervention Name(s)
placebo device
Intervention Description
use the sleep pillow without magnetic field modulation treatment
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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
Time Frame
5 weeks
Title
Insomnia severity index
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Parameters of sleep diary
Description
Some parameters of sleep diary
Time Frame
5 weeks
Title
Response rate
Description
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
Time Frame
5 weeks
Title
Remission rate
Description
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
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.18 to 65 years old. 2.Primary Insomnia Exclusion Criteria: Secondary Insomnia Pilot, high-altitude operator Pregnant, lactating women Patients with serious disease The researchers believe that the candidates are not eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiong Ou, M.D.
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Genereal Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Previous research plan submitted to the Ethics Committee has stated the participant information not be shared

Learn more about this trial

Magnetic Field Modulation Pillow for Insomnia Clinical Trial

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