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Completed

NCT Number: NCT03397472

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Genereal Hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic field modulation device

Device

use the device with magnetic field modulation to treat insomnia

Placebo Device

Device

use the sleep pillow without magnetic field modulation treatment

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: 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

  2. Insomnia severity index

    Time frame: 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 outcomes

  1. Parameters of sleep diary

    Time frame: 5 weeks

    Some parameters of sleep diary

  2. Response rate

    Time frame: 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

  3. Remission rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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