Hypersomnia Clinical Trial
— tDCSOfficial title:
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
Verified date | October 2021 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 39 |
Est. completion date | June 20, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | United States Air Force |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychomotor Vigilance Test | Objective measure of sleepiness. | 10 minutes | |
Primary | Epworth Sleepiness Scale | Subjective measure of sleepiness | 5 minutes | |
Secondary | Stanford Sleepiness Scale | Subjective measure of sleepiness | 5 minutes | |
Secondary | Functional Outcomes of Sleep Questionnaire | Measure of the impact of sleepiness on daytime function | 5 minutes | |
Secondary | Visual Analogue Scale | Subjective Measure of Sleepiness | 5 minutes | |
Secondary | CES-D Scale | Center for Epidemiologic Studies Depression (CES-D) Scale | 5 minutes |
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