HypersomniatDCSNCT03198156
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
A study testing Transcranial Direct Current Stimulation in people with Hypersomnia, run by Ohio State University at 1 site in United States.
Trial summary
1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy. 2. To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypersomnia
- 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
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years
- Epworth Sleepiness scale score >10
- Stable medication dosage over previous 4 weeks
- Able to understand English and read and write at the 8th grade level and give a written informed consent document.
- Stable sleep/wake schedule (that is, no rotating shift work)
- Clinical diagnosis of any of the following:
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- Idiopathic Hypersomnia
- Narcolepsy without Cataplexy
- Hypersomnia in OSA patients adequately treated with PAP therapy or dental device
- Posttraumatic hypersomnia
- Hypersomnia, unspecified
- Multiple sleep latency test (MSLT) shows fewer than two sleep onset REM periods and a mean sleep latency of ≤ 8 minutes. An MSLT is not required for inclusion of OSA patients provided their Epworth Sleepiness Scale (ESS) score is >10. Adequately treated OSA patients will be defined as: i) an average PAP usage of > 4 hours per night and a residual apnea-hypopnea index (AHI) of <10/hour based on PAP machine download during at least a 30-day period, or ii) regular use of dental device during sleep based on self-report and a prior sleep study showing an AHI <10/hour while using the dental device.
- Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of > 8 minutes will be included provided they have hypersomnia symptoms and habitually long sleep times (average of >10 hours per day) documented by actigraphy for at least 7 days.18
Who cannot join
- Self-reported habitual sleep period of < 7 hours/night
- History of automobile accident due to falling asleep while driving
- Currently taking stimulant medications such as Modafinil, Armodafinil, Methylphenidate, or Dextroamphetamnie.
- Inability to understand or read English
- Clear history of cataplexy
- Moderate or severe sleep apnea defined as an apnea-hypopnea index (AHI) of > 15/hour based on a previous sleep study and non-compliant with treatment.
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- Self-reported Substance abuse (current)
- Excessive alcohol consumption defined as:
- More than 3 glasses of wine a day
- More than 3 beers a day
- More than 60 mL of hard liquor a day
- Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
- Pregnancy, lactation
- Recent hospitalization for major surgery/major illness (within past 1 month)
- Non-removable metal or tattoos around head
- Use of implantable birth control device such as Implanon
- History of severe and frequent headaches
- Known coronary artery disease
- Seizure disorder
- Uncontrolled hypertension
- Congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
- To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy.
- To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy.
Read the detailed description
This is a randomized, sham-controlled, parallel group study. The study will last up to 5 weeks. After informed consent, subjects with idiopathic hypersomnia with an MSLT mean sleep latency of >8 minutes will undergo actigraphy and those with an average sleep time of >10 hours per day will continue with the study while those with <10 hours sleep time will be excluded. In addition, OSA subjects with complaints of hypersomnia with an ESS score <10 will also be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed as pregnancy is an exclusionary criteria.
Subjects will be randomized to receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. The randomization will be generated by means of a computer-generated random-number table. An unrestricted randomization scheme will be followed. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments. The investigator who will conduct the analysis of all outcomes will be blinded as to subject treatment assignment.
All stimulation visits will be completed within a five-consecutive day period; that is one stimulation visit may be missed provided a total of four stimulation visits are completed within a five-day period. Outcome measures will include: psychomotor vigilance test (PVT), subjective measures of sleepiness, and the Center for Epidemiologic Studies Depression (CES-D) scale. PVT will be performed pre- and post- stimulation during the first and last stimulation sessions. Subjective measures of sleepiness include the following: Epworth Sleepiness Scale (ESS), Stanford Sleepiness Scale (SSS), Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and Visual Analogue Scale (VAS).
- Conditions
- Hypersomnia
- Being tested
- Transcranial Direct Current Stimulation, Sham stimulation
- Keywords
- Transcranial Direct Current Stimulation, Without Cataplexy
- Medical subject headings
- Disorders of Excessive Somnolence
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 tDCS
tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.
Sham stimulationDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Active tDCS for 30 minutes daily for 4 sessions Receives: Device: Transcranial Direct Current Stimulation |
| Sham stimulation | Sham comparator | Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test
Objective measure of sleepiness.
Measured: 10 minutes
Epworth Sleepiness Scale
Subjective measure of sleepiness
Measured: 5 minutes
Secondary outcomes (4)
Stanford Sleepiness Scale
Subjective measure of sleepiness
Measured: 5 minutes
Functional Outcomes of Sleep Questionnaire
Measure of the impact of sleepiness on daytime function
Measured: 5 minutes
Visual Analogue Scale
Subjective Measure of Sleepiness
Measured: 5 minutes
CES-D Scale
Center for Epidemiologic Studies Depression (CES-D) Scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Sep 2017
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Why it stopped: Funding Stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypersomniaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Model description
- This is a 5 week randomized, sham-controlled, parallel group study involving subjects with any of the following diagnoses: Idiopathic Hypersomnia, Narcolepsy without Cataplexy, Hypersomnia in OSA patients adequately treated with PAP therapy or dental device, Posttraumatic hypersomnia, Hypersomnia, unspecified. Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \>8 minutes will undergo actigraphy and those with an average sleep time of \>10 hours per day will continue with the study while those with \<10 hours sleep time will be excluded. OSA subjects with complaints of hypersomnia with an ESS score \<10 will be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed. Subjects will receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Ulysses Magalang MD, Ohio State University
- Investigators
- Ulysses Magalang, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198156
- Sponsor's protocol ID
- 2016H0434
- Acronym
- tDCS
- Status last verified
- Oct 2021
- First submitted
- 21 Jun 2017
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
- ClinicalTrials.gov ID
- NCT03198156
- Acronym / sponsor ID
- tDCS / 2016H0434
- Conditions
- Hypersomnia
- Keywords
- Transcranial Direct Current Stimulation, Without Cataplexy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Stopped
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy.
- To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy.
Detailed description
This is a randomized, sham-controlled, parallel group study. The study will last up to 5 weeks. After informed consent, subjects with idiopathic hypersomnia with an MSLT mean sleep latency of >8 minutes will undergo actigraphy and those with an average sleep time of >10 hours per day will continue with the study while those with <10 hours sleep time will be excluded. In addition, OSA subjects with complaints of hypersomnia with an ESS score <10 will also be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed as pregnancy is an exclusionary criteria.
Subjects will be randomized to receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. The randomization will be generated by means of a computer-generated random-number table. An unrestricted randomization scheme will be followed. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments. The investigator who will conduct the analysis of all outcomes will be blinded as to subject treatment assignment.
All stimulation visits will be completed within a five-consecutive day period; that is one stimulation visit may be missed provided a total of four stimulation visits are completed within a five-day period. Outcome measures will include: psychomotor vigilance test (PVT), subjective measures of sleepiness, and the Center for Epidemiologic Studies Depression (CES-D) scale. PVT will be performed pre- and post- stimulation during the first and last stimulation sessions. Subjective measures of sleepiness include the following: Epworth Sleepiness Scale (ESS), Stanford Sleepiness Scale (SSS), Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a 5 week randomized, sham-controlled, parallel group study involving subjects with any of the following diagnoses: Idiopathic Hypersomnia, Narcolepsy without Cataplexy, Hypersomnia in OSA patients adequately treated with PAP therapy or dental device, Posttraumatic hypersomnia, Hypersomnia, unspecified. Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of >8 minutes will undergo actigraphy and those with an average sleep time of >10 hours per day will continue with the study while those with <10 hours sleep time will be excluded. OSA subjects with complaints of hypersomnia with an ESS score <10 will be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed. Subjects will receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: Transcranial Direct Current StimulationActive tDCS for 30 minutes daily for 4 sessions |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 - 70 years
- Epworth Sleepiness scale score >10
- Stable medication dosage over previous 4 weeks
- Able to understand English and read and write at the 8th grade level and give a written informed consent document.
- Stable sleep/wake schedule (that is, no rotating shift work)
Key exclusion criteria (21 listed)
- Self-reported habitual sleep period of < 7 hours/night
- History of automobile accident due to falling asleep while driving
- Currently taking stimulant medications such as Modafinil, Armodafinil, Methylphenidate, or Dextroamphetamnie.
- Inability to understand or read English
- Clear history of cataplexy
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: tDCStDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region. | Device | Transcranial Direct Current Stimulation |
| Sham stimulationSham stimulation | Device | Sham stimulation |
Primary outcome
Psychomotor Vigilance Test
Time frame: 10 minutes
Objective measure of sleepiness.
Epworth Sleepiness Scale
Time frame: 5 minutes
Subjective measure of sleepiness
4 secondary outcomes
Stanford Sleepiness Scale
Time frame: 5 minutes
Functional Outcomes of Sleep Questionnaire
Time frame: 5 minutes
Visual Analogue Scale
Time frame: 5 minutes
CES-D Scale
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ulysses Magalang, MD principal investigator
Ohio State University
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 Hypersomnia, run by Ohio State University at 1 site in United States.
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 13 inclusion and 21 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: stopped early, as of the sponsor's last update on 25 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Psychomotor Vigilance Test (time frame: 10 minutes). 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 Oct 2021.