InsomniaNCT05053919
Schumann Resonance and Insomnia
A study testing Schumann resonance sleep device in people with Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Schumann resonance sleep device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jul 2021to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333423
Yu-shu Huang, MD.PhD., 886-975365659, yushuhuang1212@gmail.com
About this study
Official title: Sleep Improvement of Schumann Resonance in the Treatment of Insomnia-A Randomized and Double-blinded Study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Schumann resonance sleep device, Placebo sleep device
- Keywords
- Insomnia, Schumann resonance, Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| SR device group | Experimental | Not described Receives: Device: Schumann resonance sleep device |
| placebo device group | Placebo comparator | Not described Receives: Device: Placebo sleep device |
What is being measured
The primary outcome is the main question the study is designed to answer.
actigraphy
Change in sleep latency (mins) based on actigraphy from before treatment to after treatment.
Measured: 4 weeks
Secondary outcomes (14)
actigraphy-TST
Total sleep time (TST, mins) based on actigraphy from before treatment to after treatment.
Measured: 4 weeks
actigraphy-SE
Sleep efficiency (SE, %) based on actigraphy from before treatment to after treatment.
Measured: 4 weeks
actigraphy-WASO
Wake after sleep onset (WASO) based on actigraphy from before treatment to after treatment.
Measured: 4 weeks
polysomnography (PSG)-SL
Change in sleep latency (SL, mins) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
polysomnography (PSG)-TST
Change in total sleep time (TST, mins) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
polysomnography (PSG)-SE
Change in sleep efficiency (SE, %) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
polysomnography (PSG)-WASO
Change in wake after sleep onset (WASO, mins) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
polysomnography (PSG)-SWS
Change in slow wave sleep (SWS, %) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
polysomnography (PSG)-REM
Change in REM sleep (%) based on PSG from before treatment to after treatment.
Measured: before and after 4 weeks using sleep device
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.
Measured: before, after 2 weeks, and after 4 weeks using sleep device
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.
Measured: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary (sleep logs)-SL
From the diaries, an estimate was computed for an average of sleep latency (SL, mins).
Measured: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary (sleep logs)-TST
From the diaries, an estimate was computed for an average of total sleep time (TST, mins).
Measured: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary questionaire (sleep logs)-SE
From the diaries, an estimate was computed for an average of sleep efficiency (SE, %).
Measured: before, after 2 weeks, and after 4 weeks using sleep device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start27 Jul 2021
- Primary completion19 Jan 2022 (estimated)
- Study completion19 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053919
- Sponsor's protocol ID
- 202101267B0
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Improvement of Schumann Resonance in the Treatment of Insomnia-A Randomized and Double-blinded Study
- ClinicalTrials.gov ID
- NCT05053919
- Acronym / sponsor ID
- 202101267B0
- Conditions
- Insomnia
- Keywords
- Insomnia, Schumann resonance, Polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 19 Jan 2022 (estimated)
- Study completion
- 19 Jan 2022 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR device group | Experimental | Device: Schumann resonance sleep device |
| placebo device group | Placebo comparator | Device: Placebo sleep device |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schumann resonance sleep deviceA 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. | Device | SR device group |
| Placebo sleep deviceA 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. | Device | placebo device group |
Primary outcome
actigraphy
Time frame: 4 weeks
Change in sleep latency (mins) based on actigraphy from before treatment to after treatment.
14 secondary outcomes
actigraphy-TST
Time frame: 4 weeks
actigraphy-SE
Time frame: 4 weeks
actigraphy-WASO
Time frame: 4 weeks
polysomnography (PSG)-SL
Time frame: before and after 4 weeks using sleep device
polysomnography (PSG)-TST
Time frame: before and after 4 weeks using sleep device
polysomnography (PSG)-SE
Time frame: before and after 4 weeks using sleep device
polysomnography (PSG)-WASO
Time frame: before and after 4 weeks using sleep device
polysomnography (PSG)-SWS
Time frame: before and after 4 weeks using sleep device
polysomnography (PSG)-REM
Time frame: before and after 4 weeks using sleep device
Pittsburgh Sleep Quality Index (PSQI)
Time frame: before, after 2 weeks, and after 4 weeks using sleep device
36-Item Short-Form Health Survey (SF-36)
Time frame: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary (sleep logs)-SL
Time frame: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary (sleep logs)-TST
Time frame: before, after 2 weeks, and after 4 weeks using sleep device
sleep diary questionaire (sleep logs)-SE
Time frame: before, after 2 weeks, and after 4 weeks using sleep device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schumann resonance sleep device in people with Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-shu Huang, MD.PhD. (886-975365659, yushuhuang1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
actigraphy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.