Magnetic Field Modulation Pillow for Insomnia Clinical Trial

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Completed

Conditions: Insomnia

Treatments: Device: placebo device; Device: magnetic field modulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT03397472

GDREC2017326H(R1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

use the sleep pillow with the magnetic field modulation treatment

Treatment:

Device: magnetic field modulation device

placebo group

Placebo Comparator group

Description:

use the sleep pillow without magnetic field modulation treatment

Treatment:

Device: placebo device