Primary InsomniaNCT02832804
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
A study testing transcranial Direct Current Stimulation in people with Primary Insomnia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia . Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to May 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (older than 19 years)
- primary insomnia
- right handed
- agree with participation of this study
Who cannot join
- diagnosed with epilepsy or history of seizure
- change of antipsychotic drug within 1 month
- under suspicion of sleep apnea or periodic limb movement disorder
- mental retardation (IQ < 70)
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
Read the detailed description
- visit 1
- to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
- EEG
- visit 2-6
- tDCS stimulation (monday ~ friday)
- anodal / cathodal / sham
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
- visit 7 : 1 week after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
- EEG
- visit 8 : 1 month after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
- analysis the results of sleep log
- Conditions
- Primary Insomnia
- Being tested
- transcranial Direct Current Stimulation
- 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.
transcranial Direct Current StimulationDevice
Also called HDCstim (direct current stimulator)
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| anodal stimulation | Experimental | 10 person The patients treated by anodal stimulation (2mA) for 20 minutes Receives: Device: transcranial Direct Current Stimulation |
| cathodal stimulation | Active comparator | 10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes Receives: Device: transcranial Direct Current Stimulation |
| sham stimulation | Sham comparator | 10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds Receives: Device: transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep log and actiwatch
Changes of sleep quality
Measured: Change from baseline at 1 week
Secondary outcomes (3)
questionnaire
Measured: Change from baseline at 1 month
EEG spectrum analysis
Measured: Change from baseline at 1 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Change from baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Sep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki-Young Jung, Seoul National University Hospital
- Investigators
- Ki-Young Jung, professor, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832804
- Sponsor's protocol ID
- 1509-061-703
- Status last verified
- Sep 2021
- First submitted
- 18 Apr 2016
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
- ClinicalTrials.gov ID
- NCT02832804
- Acronym / sponsor ID
- 1509-061-703
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
Detailed description
- visit 1
- to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
- EEG
- visit 2-6
- tDCS stimulation (monday ~ friday)
- anodal / cathodal / sham
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
- visit 7 : 1 week after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
- EEG
- visit 8 : 1 month after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
- analysis the results of sleep log
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anodal stimulation | Experimental | Device: transcranial Direct Current Stimulation10 person The patients treated by anodal stimulation (2mA) for 20 minutes |
| cathodal stimulation | Active comparator | Device: transcranial Direct Current Stimulation10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes |
| sham stimulation | Sham comparator | Device: transcranial Direct Current Stimulation10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult (older than 19 years)
- primary insomnia
- right handed
- agree with participation of this study
Key exclusion criteria (5 listed)
- diagnosed with epilepsy or history of seizure
- change of antipsychotic drug within 1 month
- under suspicion of sleep apnea or periodic limb movement disorder
- mental retardation (IQ < 70)
- pregnant woman
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 |
|---|---|---|
| transcranial Direct Current StimulationAlso: HDCstim (direct current stimulator)Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds | Device | anodal stimulation, cathodal stimulation, sham stimulation |
Primary outcome
sleep log and actiwatch
Time frame: Change from baseline at 1 week
Changes of sleep quality
3 secondary outcomes
questionnaire
Time frame: Change from baseline at 1 month
EEG spectrum analysis
Time frame: Change from baseline at 1 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Change from baseline at 1 month
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 24 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.
Ki-Young Jung, professor study chair
Seoul National University 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 transcranial Direct Current Stimulation in people with Primary Insomnia, run by Seoul National University Hospital at 1 site in South Korea.
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 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 24 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 South Korea. 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?
sleep log and actiwatch (time frame: Change from baseline at 1 week). 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 24 Sep 2021.