InsomniaNCT03397472
Magnetic Field Modulation Pillow for Insomnia Clinical Trial
A study testing magnetic field modulation device in people with Insomnia, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- magnetic field modulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2018to 30 Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 to 65 years old. 2.Primary Insomnia
Who cannot join
- Secondary Insomnia
- Pilot, high-altitude operator
- Pregnant, lactating women
- Patients with serious disease
- The researchers believe that the candidates are not eligible
Trial locations and contacts
1 site in 1 country.
About this study
This interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment.
Read the detailed description
Patients with insomnia receiving this sleep pillow with magnetic system or not would be observed in months.The effect of sleep pillow with magnetic system for insomnia would evaluated.
- Conditions
- Insomnia
- Being tested
- magnetic field modulation device, placebo device
- Keywords
- Insomnia, Treatment, magnetic field modulation
- 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.
magnetic field modulation deviceDevice
use the device with magnetic field modulation to treat insomnia
placebo deviceDevice
use the sleep pillow without magnetic field modulation treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | use the sleep pillow with the magnetic field modulation treatment Receives: Device: magnetic field modulation device |
| placebo group | Placebo comparator | use the sleep pillow without magnetic field modulation treatment Receives: Device: placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The Sleep Quality of Patients with insomnia as Reflected by PSQI scale.The PSQI scale, consisting of 18 self-rated items, was used to assess the subjects' sleep quality in the last month.The 18 self-rated items can be combined into seven factors: sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function.Each factor was scored on a scale of 0-3, and the total score of each factor was the total score of PSQI, with the total score ranging from 0-21. The higher the score was, the worse the sleep quality was
Measured: 5 weeks
Insomnia severity index
The severity of insomnia was graded by ISI score，The total score of ISI was 8-14 for mild insomnia, 15-21 for moderate insomnia and 22 for severe insomnia.
Measured: 5 weeks
Secondary outcomes (3)
Parameters of sleep diary
Some parameters of sleep diary
Measured: 5 weeks
Response rate
The total score of Insomnia severity index (ISI) decreased by 50% compared with that before treatment or less than 9 points after treatment will be judged to be responsive. Total number of responsive subject after observation/total number of subject in the group*100%= response rate
Measured: 5 weeks
Remission rate
The total score of Insomnia severity index (ISI) less than 9 points after treatment will be judged to be remissive. Total number of remissive subject after observation/total number of subject in the group*100%= remission rate
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start18 Jan 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
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 Guangdong Provincial People's 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiong Ou, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397472
- Sponsor's protocol ID
- GDREC2017326H(R1)
- Status last verified
- Dec 2018
- First submitted
- 4 Jan 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Previous research plan submitted to the Ethics Committee has stated the participant information not be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Field Modulation Pillow for Insomnia Clinical Trial
- ClinicalTrials.gov ID
- NCT03397472
- Acronym / sponsor ID
- GDREC2017326H(R1)
- Conditions
- Insomnia
- Keywords
- Insomnia, Treatment, magnetic field modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 12 Jan 2018 (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.
This interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment.
Detailed description
Patients with insomnia receiving this sleep pillow with magnetic system or not would be observed in months.The effect of sleep pillow with magnetic system for insomnia would evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: magnetic field modulation deviceuse the sleep pillow with the magnetic field modulation treatment |
| placebo group | Placebo comparator | Device: placebo deviceuse the sleep pillow without magnetic field modulation treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 to 65 years old. 2.Primary Insomnia
Key exclusion criteria (5 listed)
- Secondary Insomnia
- Pilot, high-altitude operator
- Pregnant, lactating women
- Patients with serious disease
- The researchers believe that the candidates are not eligible
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 |
|---|---|---|
| magnetic field modulation deviceuse the device with magnetic field modulation to treat insomnia | Device | treatment group |
| placebo deviceuse the sleep pillow without magnetic field modulation treatment | Device | placebo group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 5 weeks
The Sleep Quality of Patients with insomnia as Reflected by PSQI scale.The PSQI scale, consisting of 18 self-rated items, was used to assess the subjects' sleep quality in the last month.The 18 self-rated items can be combined into seven factors: sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function.Each factor was scored on a scale of 0-3, and the total score of each factor was the total score of PSQI, with the total score ranging from 0-21. The higher the score was, the worse the sleep quality was
Insomnia severity index
Time frame: 5 weeks
The severity of insomnia was graded by ISI score，The total score of ISI was 8-14 for mild insomnia, 15-21 for moderate insomnia and 22 for severe insomnia.
3 secondary outcomes
Parameters of sleep diary
Time frame: 5 weeks
Response rate
Time frame: 5 weeks
Remission rate
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. Previous research plan submitted to the Ethics Committee has stated the participant information not be shared
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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.
Qiong Ou, M.D. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic field modulation device in people with Insomnia, run by Guangdong Provincial People's Hospital at 1 site in China.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 25 Mar 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 25 Mar 2020.