Schumann Resonance and Insomnia

Insomnia Clinical Trial

Official title:

Sleep Improvement of Schumann Resonance in the Treatment of Insomnia-A Randomized and Double-blinded Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053919
• Other study ID #: 202101267B0
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: January 19, 2022

Study information

• Verified date: August 2021
• Source: Chang Gung Memorial Hospital
• Contact: Yu-shu Huang, MD.PhD.
• Phone: 886-975365659
• Email: yushuhuang1212[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Insomnia is a common sleep disturbance that affects the health and quality of life of individuals and accounts for considerable utilization of medical resources. The prevalence of insomnia is approximately 30%; in Asia, the prevalence of insomnia is approximately 4% in Japan, 9.9% in South Korea, 10.3% in Taiwan. Based on the statistic of Taiwan BNHI office in a 2013 report, there is worth of 1.3 billion prescriptions of hypnotic drug in one year. In addition, the reimbursement expenditure pays up more than 1 billion New Taiwan Dollars (NTD) with increasing expense rate of 15% every year, showing insomnia causes great distress to Taiwanese.

The characteristics of insomnia are difficulty with initiating or maintaining sleep, early morning waking, or non-restorative sleep. In DSM-5, the diagnosis of primary insomnia has been renamed insomnia disorder to avoid the differentiation between primary and secondary insomnia.

The most common treatment for insomnia is pharmacological therapy with hypnotics such as a benzodiazepine, zolpidem, or zopiclone. However, treatment with hypnotics includes the risk of adverse effects, drug tolerance and dependence . Some past reports on different non-pharmacological treatment strategies, such as Cognitive-Behavioral Therapy (CBT), muscle relaxation training, stimulus control, sleep restriction, and sleep hygiene, have demonstrated the effectiveness of most of these non-pharmacological treatments. However, the poor compliance and inconvenience for CBT is always a big issue.

Except the traditional treatment of insomnia, some folk therapies' clinical effect does not been confirmed, such as aromatherapy, music therapy, etc. Nowadays, due to development of technology for medical devices, some sleep devices were launched, aim to prolong the slow-wave sleep and enhances the sleeping quality.

The investigational device in this study is a sleep device with SRF (Sleep Restore Frequency), the principle is to integrate the bio-energy generated Schumann resonances, native from Earth, and the shocks from the Earth's magnetic field. Through the non-contact method with bio-energy waves, SRF are coupled to the sleep center of the brain, inducing and adjusting the electrical activities of the sleep center. It prolongs the in-depth sleep and enhances the sleeping quality.

The objective of this study is (1) to evaluate the improvement of sleep quality of patients with insomnia disorder by sleep device and (2) to be the basis for the future development of physical magnetic therapy.

Sample Size Approximately 60 subjects who meet the inclusion and exclusion criteria will be enrolled into the trial and averagely separated two arms for statistical analysis.

Statistical Analysis Efficacy evaluation statistics will be conducted with independent t-test or Fisher's exact test for testing the differences and conducted with Pearson correlation coefficient for the association between variables.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Schumann resonance sleep device
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.
• Placebo sleep device
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate variability (HRV) device	The measurement method is to stick four patches on participants body and measure the heart rhythm state for 10 minutes. An estimate was computed for LF/HF ratio.	before, after 2 weeks, and after 4 weeks using sleep device
Primary	actigraphy	Change in sleep latency (mins) based on actigraphy from before treatment to after treatment.	4 weeks
Secondary	actigraphy-TST	Total sleep time (TST, mins) based on actigraphy from before treatment to after treatment.	4 weeks
Secondary	actigraphy-SE	Sleep efficiency (SE, %) based on actigraphy from before treatment to after treatment.	4 weeks
Secondary	actigraphy-WASO	Wake after sleep onset (WASO) based on actigraphy from before treatment to after treatment.	4 weeks
Secondary	polysomnography (PSG)-SL	Change in sleep latency (SL, mins) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	polysomnography (PSG)-TST	Change in total sleep time (TST, mins) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	polysomnography (PSG)-SE	Change in sleep efficiency (SE, %) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	polysomnography (PSG)-WASO	Change in wake after sleep onset (WASO, mins) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	polysomnography (PSG)-SWS	Change in slow wave sleep (SWS, %) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	polysomnography (PSG)-REM	Change in REM sleep (%) based on PSG from before treatment to after treatment.	before and after 4 weeks using sleep device
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire for assessing the subjective sleep quality, which consists of 19 items and can be calculated and combined into 7 clinically-derived component score (0-3), with higher scores indicating worse sleep quality.	before, after 2 weeks, and after 4 weeks using sleep device
Secondary	36-Item Short-Form Health Survey (SF-36)	36-Item Short-Form Health Survey (SF-36) includes 11 major questions that evaluate eight components (0-100), with higher scores indicating better outcome.These components include physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health.	before, after 2 weeks, and after 4 weeks using sleep device
Secondary	sleep diary (sleep logs)-SL	From the diaries, an estimate was computed for an average of sleep latency (SL, mins).	before, after 2 weeks, and after 4 weeks using sleep device
Secondary	sleep diary (sleep logs)-TST	From the diaries, an estimate was computed for an average of total sleep time (TST, mins).	before, after 2 weeks, and after 4 weeks using sleep device
Secondary	sleep diary questionaire (sleep logs)-SE	From the diaries, an estimate was computed for an average of sleep efficiency (SE, %).	before, after 2 weeks, and after 4 weeks using sleep device