NCT05053919

Brief Summary

The double-blinded and randomized study evaluated the effectiveness and side effects of a novel non-invasive treatment, Schumann resonance (SR), in treating insomnia. The objective of this study is (1) to evaluate the improvement of sleep quality of patients with insomnia disorder by SR and (2) to be the basis for the future development of physical magnetic therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

September 23, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 6, 2021

Last Update Submit

September 13, 2021

Conditions

Insomnia

Keywords

InsomniaSchumann resonancePolysomnography

Outcome Measures

Primary Outcomes (1)

  • actigraphy

    Change in sleep latency (mins) based on actigraphy from before treatment to after treatment.

    4 weeks

Secondary Outcomes (14)

  • actigraphy-TST

    4 weeks

  • actigraphy-SE

    4 weeks

  • actigraphy-WASO

    4 weeks

  • polysomnography (PSG)-SL

    before and after 4 weeks using sleep device

  • polysomnography (PSG)-TST

    before and after 4 weeks using sleep device

  • +9 more secondary outcomes

Other Outcomes (1)

  • heart rate variability (HRV) device

    before, after 2 weeks, and after 4 weeks using sleep device

Study Arms (2)

SR device group

EXPERIMENTAL
Device: Schumann resonance sleep device

placebo device group

PLACEBO COMPARATOR
Device: Placebo sleep device

Interventions

Schumann resonance sleep deviceDEVICE

A Schumann resonance sleep device would stably output the composite frequency of a "the Schumann resonance frequency (7.83 Hz) wave, theta wave, and delta wave". The subjects were asked to use the device (place it next to the bed facing the subject's head, turn it on about one hour before going to bed every night, and turn it off after getting up the next day) every night for four weeks.

SR device group
Placebo sleep deviceDEVICE

A Placebo sleep device is an instrument with the same appearance and operation as the Schumann resonance sleep device, but does not output any frequency wave. The subjects were asked to use the device (place it next to the bed facing the subject's head, turn it on about one hour before going to bed every night, and turn it off after getting up the next day) every night for four weeks.

placebo device group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) participants are between 20 and 70 years old;
  • (2) participants must meet the DSM-5 diagnostic criteria for insomnia and have been diagnosed for more than three months;
  • (3) participants must be willing to sign an informed consent form;
  • (4) participants who took sleep aiding pills must cooperate not to change any medication and dosage during the study.

You may not qualify if:

  • (1) participants using pacemakers or cardiac monitors;
  • (2) participants with severe physical illness or after surgery, such as heart disease, metabolic diseases, or cancer;
  • (3) participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder; or severe neurological diseases such as a seizure, stroke or Parkinson's disease;
  • (4) participants with other serious sleep disorders, such as severe sleep obstructive apnea, severe periodic limb movement syndrome or narcolepsy;
  • (5) participants who are unable to attend regular follow-up evaluations;
  • (6) participants who are unable to keep good sleep hygiene and cannot stop using electronic products before going to bed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333423, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Yu-shu Huang, MD.PhD.

CONTACT

886-975365659yushuhuang1212@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 23, 2021

Study Start

July 27, 2021

Primary Completion

January 19, 2022

Study Completion

January 19, 2022

Last Updated

September 23, 2021

Record last verified: 2021-08

Locations

TW(1)