Dimethyl Fumarate for Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; OSA; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dimethyl fumarate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dimethyl fumarate capsules will be dispensed during routine study appointments. 120 mg tablets will be dispensed to facilitate dose titrations. Drug will be dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants will be instructed to take the medication with food, in the morning and at dinnertime. If participants miss a dose, they will be instructed to resume their normal dose at the next scheduled time, and be instructed not to take an extra dose at their next dosing interval if they previously miss a dose.; Placebo capsules will be dispensed during routine study appointments. Placebo will be dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants will be instructed to take the placebo with food, in the morning and at dinnertime. If participants miss a dose, they will be instructed to resume their normal dose at the next scheduled time, and be instructed not to take an extra dose at their next dosing interval if they previously miss a dose.
Other intervention name(s): Tecfidera
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; OSA; sleep apnea; snoring; dimethyl fumarate; CPAP; continuous positive airway pressure