Obstructive Sleep Apnea Clinical Trial
Official title:
A Randomized Clinical Trial of Dimethyl Fumarate as a Novel Therapeutic Agent for Obstructive Sleep Apnea
The overall purpose of this study is to determine whether the oral medication dimethyl fumarate is an effective treatment for obstructive sleep apnea in patients who are unable, unwilling, or uneager to use positive airway pressure therapy.
Obstructive sleep apnea (OSA) is a common disorder that involves collapse of the upper
airway during sleep, leading to low blood oxygen levels and sleep disruption. Untreated OSA
increases the risk of many health consequences, including high blood pressure, heart
disease, stroke, diabetes, memory problems, fatigue, sleepiness, and impaired memory.
Despite its profound public health and societal impact, there are no known medications that
can effectively treat OSA, and up to 50% of patients cannot tolerate current treatments. The
primary treatment for OSA, known as Continuous Positive Airway Pressure (CPAP), is delivered
by a mechanical device and mask that blows air into the airway to keep it open during sleep.
Although CPAP controls OSA, many patients can't tolerate the discomfort of the mask, and up
to 50% of patients cannot use CPAP appropriately.
Several recent studies of OSA patients suggest that inflammation in the airway and the
bloodstream may worsen OSA, and that medications that control inflammation may improve OSA.
In particular, a previous study from the researchers suggests that multiple sclerosis (MS)
patients who are on MS therapies that control inflammation may have less severe OSA than
those who are not. MS is an autoimmune disease that is associated with inflammation of the
nervous system. As OSA may also be caused or worsened by inflammation, this clinical trial
aims to study the effects of a specific MS medication known as dimethyl fumarate (brand name
- Tecfidera®) to see if it may also be useful to treat OSA. Tecfidera® is already approved
by the Food and Drug Administration (FDA) to treat patients with MS. However, it is not
approved by the FDA for the treatment of OSA and is thus considered an investigational drug
in this study.
Study-related activities will last for 5 months. Consenting participants will receive a
baseline overnight sleep study to assess their current sleep apnea severity. Participants
will then be given either oral dimethyl fumarate or placebo for a period of 4 months, and
will be followed on a monthly basis during the course of the study. At the end of the study,
participants will undergo a repeat overnight sleep study to monitor for changes in their
sleep apnea severity. Treatments will be assigned at random (like flipping a coin), and
participants will not be aware of which treatment they receive. There is a 2/3 chance that
participants will receive dimethyl fumarate. Participants will also undergo blood draws and
complete several surveys during their monthly study visits. Participants will be compensated
for their travel and time throughout the course of the study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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