Hypersomnia
Conditions
Keywords
Transcranial Direct Current Stimulation, Without Cataplexy
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.
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).
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.
DEVICESham stimulation
Sham stimulation
Sponsors
United States Air Force
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Vigilance Test | 10 minutes | Objective measure of sleepiness. |
| Epworth Sleepiness Scale | 5 minutes | Subjective measure of sleepiness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stanford Sleepiness Scale | 5 minutes | Subjective measure of sleepiness |
| Functional Outcomes of Sleep Questionnaire | 5 minutes | Measure of the impact of sleepiness on daytime function |
| Visual Analogue Scale | 5 minutes | Subjective Measure of Sleepiness |
| CES-D Scale | 5 minutes | Center for Epidemiologic Studies Depression (CES-D) Scale |
Countries
United States
Participant flow
Pre-assignment details
Of 39 enrolled subjects, 38 met inclusion criteria and were randomized to treatment
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation Active tDCS for 30 minutes daily for 4 sessions
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. | 19 |
| 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.
Sham stimulation: Sham stimulation | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation | Sham Stimulation | Total |
|---|---|---|---|
| Age, Continuous | 38.63 years STANDARD_DEVIATION 11.34 | 38.84 years STANDARD_DEVIATION 14.27 | 38.73 years STANDARD_DEVIATION 25.61 |
| BMI | 29.70 kg/m^2 STANDARD_DEVIATION 5.02 | 29.84 kg/m^2 STANDARD_DEVIATION 6.67 | 29.77 kg/m^2 STANDARD_DEVIATION 5.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Epworth Sleepiness Scale
Subjective measure of sleepiness
Time frame: 5 minutes
Population: Subjective Sleepiness data based on patient report on the Epwoth Sleepiness Scale questionnaire could not be analyzed and reported in data table as were unable to be collect data from enrolled patients. This study terminated early.
Primary
Psychomotor Vigilance Test
Objective measure of sleepiness.
Time frame: 10 minutes
Population: Sleepiness measure data based on Psychomotor Vigilance Test results could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.
Secondary
CES-D Scale
Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: 5 minutes
Population: Data from Center for Epidemiologic Studies Depression (CES-D) Scale could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients
Secondary
Functional Outcomes of Sleep Questionnaire
Measure of the impact of sleepiness on daytime function
Time frame: 5 minutes
Population: Impact of sleepiness on daytime function based on functional outcomes of sleep questionnaire could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.
Secondary
Stanford Sleepiness Scale
Subjective measure of sleepiness
Time frame: 5 minutes
Population: Subjective Sleepiness data based on Stanford Sleepiness Scale instrument could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients. This study was early terminated.
Secondary
Visual Analogue Scale
Subjective Measure of Sleepiness
Time frame: 5 minutes
Population: Subjective Sleepiness data based on Visual Analogue Scale (VAS) could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.