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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hypersomnia||Device: Transcranial Direct Current Stimulation Device: Sham stimulation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
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
- Psychomotor Vigilance Test [ Time Frame: 10 minutes ]Objective measure of sleepiness.
- Epworth Sleepiness Scale [ Time Frame: 5 minutes ]Subjective measure of sleepiness
- Stanford Sleepiness Scale [ Time Frame: 5 minutes ]Subjective measure of sleepiness
- Functional Outcomes of Sleep Questionnaire [ Time Frame: 5 minutes ]Measure of the impact of sleepiness on daytime function
- Visual Analogue Scale [ Time Frame: 5 minutes ]Subjective Measure of Sleepiness
- CES-D Scale [ Time Frame: 5 minutes ]Center for Epidemiologic Studies Depression (CES-D) Scale
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
|Contact: Samantha Rojas, BAfirstname.lastname@example.org|
|Contact: Carson Reider, PhD||(614) email@example.com|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Samantha Rojas, BA 614-366-2361 firstname.lastname@example.org|
|Principal Investigator:||Ulysses Magalang, MD||The Ohio State University Wexner Medical Center|