Magnetic Field Modulation Pillow for Insomnia Clinical Trial

NCT03397472 | Completed DMC

• 1 other identifier: GDREC2017326H(R1)
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Treatment; magnetic field modulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Parameters of sleep diary

  5 weeks

• Response rate

  5 weeks

• Remission rate

  5 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

use the sleep pillow with the magnetic field modulation treatment

Device: magnetic field modulation device

placebo group

PLACEBO COMPARATOR

use the sleep pillow without magnetic field modulation treatment

Device: placebo device

Interventions

magnetic field modulation device DEVICE

use the device with magnetic field modulation to treat insomnia

treatment group

placebo device DEVICE

use the sleep pillow without magnetic field modulation treatment

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old. 2.Primary Insomnia

You may not qualify if:

• Secondary Insomnia
• Pilot, high-altitude operator
• Pregnant, lactating women
• Patients with serious disease
• The researchers believe that the candidates are not eligible

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Genereal Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Qiong Ou, M.D.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 12, 2018
• Study Start: January 18, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 25, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)