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Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy (tDCS)

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ClinicalTrials.gov Identifier: NCT03198156
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Ulysses Magalang MD, Ohio State University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypersomnia Device: Transcranial Direct Current Stimulation Device: Sham stimulation Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation
Active tDCS for 30 minutes daily for 4 sessions
Device: Transcranial Direct Current Stimulation
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.
Other Name: tDCS

Sham Comparator: Sham stimulation
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.
Device: Sham stimulation
Sham stimulation




Primary Outcome Measures :
  1. Psychomotor Vigilance Test [ Time Frame: 10 minutes ]
    Objective measure of sleepiness.

  2. Epworth Sleepiness Scale [ Time Frame: 5 minutes ]
    Subjective measure of sleepiness


Secondary Outcome Measures :
  1. Stanford Sleepiness Scale [ Time Frame: 5 minutes ]
    Subjective measure of sleepiness

  2. Functional Outcomes of Sleep Questionnaire [ Time Frame: 5 minutes ]
    Measure of the impact of sleepiness on daytime function

  3. Visual Analogue Scale [ Time Frame: 5 minutes ]
    Subjective Measure of Sleepiness

  4. CES-D Scale [ Time Frame: 5 minutes ]
    Center for Epidemiologic Studies Depression (CES-D) Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Idiopathic Hypersomnia
    2. Narcolepsy without Cataplexy
    3. Hypersomnia in OSA patients adequately treated with PAP therapy or dental device
    4. Posttraumatic hypersomnia
    5. 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

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198156


Contacts
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Contact: Samantha Rojas, BA 614-366-2361 samantha.rojas@osumc.edu
Contact: Carson Reider, PhD (614) 293-9274 carson.reider@osumc.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Samantha Rojas, BA    614-366-2361    samantha.rojas@osumc.edu   
Sponsors and Collaborators
Ohio State University
United States Air Force
Investigators
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Principal Investigator: Ulysses Magalang, MD The Ohio State University Wexner Medical Center

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Responsible Party: Ulysses Magalang MD, Professor of Medicine and Neuroscience; Director, Sleep Medicine Program, Ohio State University
ClinicalTrials.gov Identifier: NCT03198156     History of Changes
Other Study ID Numbers: 2016H0434
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ulysses Magalang MD, Ohio State University:
Transcranial Direct Current Stimulation
Without Cataplexy

Additional relevant MeSH terms:
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Disorders of Excessive Somnolence
Cataplexy
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Narcolepsy