Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT03198156
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:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03198156
Study Brief:
Protocol Section:
NCT03198156