- Idiopathic Hypersomnia
Ages Eligible for Study: 18 Years to 75 Years
- A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3 (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep latency test (MSLT) study performed within the last 10 years.
- Onset of hypersomnia between 10 and 30 years of age.
- Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
- Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m^2) inclusive. (Click here for a BMI calculator)
- Insufficient sleep syndrome
- Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
- Nicotine dependence that is likely to have an effect on sleep (eg, a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the study.
- Alcohol use that is likely to have an effect on sleep and/or an unwillingness to discontinue all alcohol use from 72 hours before check-in through discharge on Study Day 4.
- Diagnosis of major depressive disorder (DSM-5), within the past 6 months
There are additional criteria to meet in order to qualify for this research study. For more information contact us!
Study Location: Jacksonville
If you or someone you know has had a Hypersomnia, call us today! We have research studies enrolling now.
Qualified volunteers may receive at no cost:
- Investigational medication
- Study-related care from a local doctor
- Possible compensation
Ask your doctor or contact our clinic for more information
Or sign up below!
- Differentiating Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare neurological sleep disorder that can drastically affect a person’s life. Those suffering from IH have a hard time staying awake and alert during the day. They may fall asleep at inappropriate times and not notice.
There is no FDA approved treatment for IH. Some can take medication, typically taken for narcolepsy, to improve symptoms. Unlike narcolepsy, scheduled naps will not help those suffering from IH. A key symptom that differentiates IH from other sleep disorders is long naps that are not refreshing with no known cause.
IH’s symptoms are severe and typically disrupt daily activities. It can be difficult to drive, work, go to school and do other daily tasks we take for granted. To better understand IH we need to learn the symptoms. Common symptoms include:
- Chronic excessive daytime sleepiness: sleepiness during the day that makes it hard to perform tasks
- Sleeping 9 hours or more over 24-hour periods yet not feeling refreshed upon waking up
- Non-refreshing daytime napping
- Sleep drunkenness: waking up and feeling the desire to go back to sleep
- Experiencing problems with memory, attention and concentration
As mentioned, there is no known FDA approved treatment for IH. The treatment is usually aimed at addressing the excessive daytime sleepiness over other symptoms, typically with medication. What really sets IH apart and differentiates it from other sleeping conditions is that it usually can not be improved through lifestyle changes. Those with IH do not have energizing sleep, so frequent planned naps and improving sleep at night typically do not work.
Participating in clinical trials is one of the best ways to find a cure for IH, or improve the symptoms and create a better quality of life.
Source: Generic and Rare Disease Information Center, Medline Plus
This research study is enrolling at:
Jacksonville Center for Clinical Research
4085 University Blvd., South, Suite 1
Jacksonville, FL 32216