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

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.

Study Overview

• Status: Terminated
• Conditions: Hypersomnia
• Intervention / Treatment: Device: Sham stimulation; Device: Transcranial Direct Current Stimulation

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychomotor Vigilance Test	Objective measure of sleepiness.	10 minutes
Epworth Sleepiness Scale	Subjective measure of sleepiness	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stanford Sleepiness Scale	Subjective measure of sleepiness	5 minutes
Functional Outcomes of Sleep Questionnaire	Measure of the impact of sleepiness on daytime function	5 minutes
Visual Analogue Scale	Subjective Measure of Sleepiness	5 minutes
CES-D Scale	Center for Epidemiologic Studies Depression (CES-D) Scale	5 minutes

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: United States Air Force

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): June 20, 2020
• Study Completion (ACTUAL): June 20, 2020

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (ACTUAL): June 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Without Cataplexy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Narcolepsy; Disorders of Excessive Somnolence; Cataplexy
• Other Study ID Numbers: 2016H0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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