A randomized, double-blind, controlled study for the therapy of chronic insomnia, based on the electric field modulation

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100043690

Enrollment

Unknown

Registered

2021-02-27

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia

Interventions

A:Electronic Pillow NPD-2000M1

B:Blank control group of Electronic Pillow

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of ICSD-3 for chronic insomnia. 2) Beck depression score < 20. 3) Aged 18-75 years, regardless of sex. 4) Those who can not only understand and comply with the research scheme, but also voluntarily participate in the clinical study and have signed the informed consent form. 5) Own and know how to use smart terminals (e. G. smart phones, tablets, computers, etc.).

Exclusion criteria

Exclusion criteria: 1) Wear a life-sustaining non-invasive / invasive ventilator. 2) suffering from heart disease or equipped with a pacemaker. 3) equipped with hearing aids or cochlear implants. 4) emotional instability in the early stage of pregnancy or after delivery. 5) suffering from sensory impairment due to advanced peripheral circulation disorders caused by diabetes, etc. 6) patients with acute inflammation or high fever (including covid-19 infection). 7) suffering from a malignant tumor (such as a tumor) or debilitating and being treated, requiring special recuperation. 8) suffering from acute pain diseases, such as awareness of spinal sprains, muscle tears or fractures. 9) patients with other sleep disorders, or with other medical, neurological and mental disorders, such as thyroid dysfunction, dementia, Parkinson's syndrome, schizophrenia, etc. 10) shift workers, night shift workers, frequent cross-time zone fliers (such as crew members of international flights). 11) the researchers do not think it is appropriate to participate in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Polysomnogram;Pittsburgh sleep quality index scale;	—

Secondary

Measure	Time frame
Huawei bracelet;Sleep diary;	—

Countries

China

Contacts

Public ContactHuijuan Wu

Changzheng Hospital Affiliated to PLA Naval Medical University

huijuan.w@163.com+86 13621837012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026