Clinical trial NCT05053919: Schumann Resonance and Insomnia
Official title: Sleep Improvement of Schumann Resonance in the Treatment of Insomnia-A Randomized and Double-blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Schumann resonance
Polysomnography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: actigraphy
timeFrame: 4 weeks
Secondary outcomes:
measure: actigraphy-TST
timeFrame: 4 weeks
measure: actigraphy-SE
timeFrame: 4 weeks
measure: actigraphy-WASO
timeFrame: 4 weeks
measure: polysomnography (PSG)-SL
timeFrame: before and after 4 weeks using sleep device
measure: polysomnography (PSG)-TST
timeFrame: before and after 4 weeks using sleep device
measure: polysomnography (PSG)-SE
timeFrame: before and after 4 weeks using sleep device
measure: polysomnography (PSG)-WASO
timeFrame: before and after 4 weeks using sleep device
measure: polysomnography (PSG)-SWS
timeFrame: before and after 4 weeks using sleep device
measure: polysomnography (PSG)-REM
timeFrame: before and after 4 weeks using sleep device
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
measure: sleep diary (sleep logs)-SL
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
measure: sleep diary (sleep logs)-TST
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
measure: sleep diary questionaire (sleep logs)-SE
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
Other outcomes:
measure: heart rate variability (HRV) device
timeFrame: before, after 2 weeks, and after 4 weeks using sleep device
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
References: