CClinicalTrials.gg
Sign In
TerminatedNCT03198156tDCSUpdated Oct 25, 2021Results posted

Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy

An interventional study of Transcranial Direct Current Stimulation and Sham stimulation in Hypersomnia, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding Stopped
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Hypersomnia

Keywords

  • Transcranial Direct Current Stimulation
  • Without Cataplexy
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Transcranial Direct Current Stimulation

    Active tDCS for 30 minutes daily for 4 sessions

    Device: Transcranial Direct Current Stimulation

  • 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

Interventions

  • DeviceTranscranial 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.

    Also known as: tDCS

  • DeviceSham stimulation

    Sham stimulation

05

What researchers measure

Primary outcomes

  1. Psychomotor Vigilance Test

    Objective measure of sleepiness.

    Time frame: 10 minutes

  2. Epworth Sleepiness Scale

    Subjective measure of sleepiness

    Time frame: 5 minutes

Secondary outcomes

  1. Stanford Sleepiness Scale

    Subjective measure of sleepiness

    Time frame: 5 minutes

  2. Functional Outcomes of Sleep Questionnaire

    Measure of the impact of sleepiness on daytime function

    Time frame: 5 minutes

  3. Visual Analogue Scale

    Subjective Measure of Sleepiness

    Time frame: 5 minutes

  4. CES-D Scale

    Center for Epidemiologic Studies Depression (CES-D) Scale

    Time frame: 5 minutes

06

Results

Posted Oct 25, 2021
Limitations and caveats
No data was analyzed. Study was terminated due to the funding was stopped.

Participant flow

Participant flow — Overall Study
MilestoneTranscranial Direct Current StimulationSham Stimulation
Started1919
Completed1919
Not completed00

Outcome measures

PrimaryPsychomotor Vigilance Test

Objective measure of sleepiness.

Time frame:
10 minutes

No measurements were reported for this outcome.

PrimaryEpworth Sleepiness Scale

Subjective measure of sleepiness

Time frame:
5 minutes

No measurements were reported for this outcome.

SecondaryStanford Sleepiness Scale

Subjective measure of sleepiness

Time frame:
5 minutes

No measurements were reported for this outcome.

SecondaryFunctional Outcomes of Sleep Questionnaire

Measure of the impact of sleepiness on daytime function

Time frame:
5 minutes

No measurements were reported for this outcome.

SecondaryVisual Analogue Scale

Subjective Measure of Sleepiness

Time frame:
5 minutes

No measurements were reported for this outcome.

SecondaryCES-D Scale

Center for Epidemiologic Studies Depression (CES-D) Scale

Time frame:
5 minutes

No measurements were reported for this outcome.

Adverse events

Collected over Adverse events were assessed through study completion (5 weeks for each participant).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Transcranial Direct Current Stimulation0/19 (0%)0/19 (0%)0/19 (0%)
Sham Stimulation0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Transcranial Direct Current StimulationSham StimulationTotal
Mean38.63 ± 11.3438.84 ± 14.2738.73 ± 25.61
Sex: Female, Male
Sex: Female, Male(Participants)Transcranial Direct Current StimulationSham StimulationTotal
Female101222
Male9716
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Transcranial Direct Current StimulationSham StimulationTotal
American Indian or Alaska Native000
Asian033
Native Hawaiian or Other Pacific Islander000
Black or African American213
White151530
More than one race202
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Transcranial Direct Current StimulationSham StimulationTotal
United States191938
BMI
BMI(kg/m^2)Transcranial Direct Current StimulationSham StimulationTotal
Mean29.70 ± 5.0229.84 ± 6.6729.77 ± 5.26
07

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 29, 2019
  • Informed consent form · Jan 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03198156
Lead sponsor
Ohio State University
Collaborators
United States Air Force
Responsible party
Ulysses Magalang MD (Professor of Medicine and Neuroscience; Director, Sleep Medicine Program, Ohio State University) — Principal investigator
First posted
Jun 26, 2017
Start date
Sep 1, 2017
Primary completion
Jun 20, 2020
Completion
Jun 20, 2020
Results posted
Oct 25, 2021
Last update
Oct 25, 2021

Study contacts

Ulysses Magalang, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Disorders of Excessive Somnolence→

Other studies from this sponsor

Ohio State University

Start the discussion