Magnetic Field Modulation Pillow for Insomnia Clinical Trial

NCT ID: NCT03397472

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment group

use the sleep pillow with the magnetic field modulation treatment

Group Type EXPERIMENTAL

magnetic field modulation device

Intervention Type DEVICE

use the device with magnetic field modulation to treat insomnia

placebo group

use the sleep pillow without magnetic field modulation treatment

Group Type PLACEBO_COMPARATOR

placebo device

Intervention Type DEVICE

use the sleep pillow without magnetic field modulation treatment

Interventions

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magnetic field modulation device

use the device with magnetic field modulation to treat insomnia

Intervention Type DEVICE

placebo device

use the sleep pillow without magnetic field modulation treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiong Ou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong Genereal Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GDREC2017326H(R1)

Identifier Type: -

Identifier Source: org_study_id

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