Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-07-27
2022-01-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SR device group
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 device group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* (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
* (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.
20 Years
70 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202101267B0
Identifier Type: -
Identifier Source: org_study_id
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