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

Primary Purpose

Hypersomnia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham stimulation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersomnia focused on measuring Transcranial Direct Current Stimulation, Without Cataplexy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation

Sham stimulation

Arm Description

Active tDCS for 30 minutes daily for 4 sessions

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.

Outcomes

Primary Outcome Measures

Psychomotor Vigilance Test
Objective measure of sleepiness.
Epworth Sleepiness Scale
Subjective measure of sleepiness

Secondary Outcome Measures

Stanford Sleepiness Scale
Subjective measure of sleepiness
Functional Outcomes of Sleep Questionnaire
Measure of the impact of sleepiness on daytime function
Visual Analogue Scale
Subjective Measure of Sleepiness
CES-D Scale
Center for Epidemiologic Studies Depression (CES-D) Scale

Full Information

First Posted
June 21, 2017
Last Updated
October 22, 2021
Sponsor
Ohio State University
Collaborators
United States Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT03198156
Brief Title
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
Acronym
tDCS
Official Title
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding Stopped
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
United States Air Force

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersomnia
Keywords
Transcranial Direct Current Stimulation, Without Cataplexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
Active tDCS for 30 minutes daily for 4 sessions
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Sham stimulation
Primary Outcome Measure Information:
Title
Psychomotor Vigilance Test
Description
Objective measure of sleepiness.
Time Frame
10 minutes
Title
Epworth Sleepiness Scale
Description
Subjective measure of sleepiness
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Stanford Sleepiness Scale
Description
Subjective measure of sleepiness
Time Frame
5 minutes
Title
Functional Outcomes of Sleep Questionnaire
Description
Measure of the impact of sleepiness on daytime function
Time Frame
5 minutes
Title
Visual Analogue Scale
Description
Subjective Measure of Sleepiness
Time Frame
5 minutes
Title
CES-D Scale
Description
Center for Epidemiologic Studies Depression (CES-D) Scale
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulysses Magalang, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy

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