Dimethyl Fumarate for Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; OSA; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Dimethyl fumarate; Placebo
Intervention description: 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.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; OSA; sleep apnea; snoring; dimethyl fumarate; CPAP; continuous positive airway pressure

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of 18-65 years at screening;

          2. Diagnosis of OSA as confirmed by previous clinical sleep study (polysomnography, PSG);

          3. Refusal, inability, or high reluctance to use CPAP regularly for treatment of OSA,
             despite medical advice;

          4. Willingness to undergo repeat sleep study (PSG) and blood studies;

          5. Normal immune cell counts, as evidenced by complete blood count (CBC) done at
             screening

        Exclusion Criteria:

          1. Regular use of CPAP within the last 2 months

          2. Physical, psychiatric or cognitive impairment that prevents informed consent, PSG, or
             reliable follow-up;

          3. Cardiac conditions that may increase sleep apnea severity (e.g., congestive heart
             failure or recent heart attack);

          4. Current successful treatment for obstructive or central sleep apnea, for example by
             CPAP, and patient agreement to continue with that treatment;

          5. History of surgical treatment for OSA within past 6 months, or subsequent to last PSG
             confirmation that OSA is present;

          6. Active nervous system diseases that may predispose subjects to OSA;

          7. Systemic autoimmune disease that could increase inflammation and influence apnea
             severity (such as rheumatoid arthritis or lupus);

          8. Pregnancy or breastfeeding;

          9. Use of immunotherapies or immunosuppressants, currently or within past 6 months;

         10. Anticipated initiation or dose change in tricyclic antidepressants, selective
             serotonin uptake inhibitors, or related compounds;

         11. Participants with a history of active, serious or persistent infections.

         12. Participants with recent surgery (within 3 months prior to screening), or anticipated
             surgery during the length of the study.

         13. Systemic steroid use within the last 2 months (does not include local steroid
             injections or intranasal steroid spray);

         14. Current diagnosis of cancer that is not considered to be cured or in remission by the
             treating physician, cancer treatment of any kind within the last 6 months prior to
             screening (chemo, radiation, surgery), or anticipated cancer treatment during the
             length of the study;

         15. History of a lymphoproliferative disorder (such as leukemia);

         16. History of Multiple Myeloma

         17. History of decreased immune cell counts per a blood test known as a CBC, specifically
             lymphocyte counts less than 1.2 K/μL at screening.

         18. Refusal to use at least one reliable method of birth control (for women of
             childbearing age)

         19. Newly diagnosed (within 2 months) OSA subjects who have an AHI > 30 and history of
             serious, recent, or unstable cardiovascular disease (including but not limited to
             recent MI, recent stroke/TIA, or unstable angina)

         20. Participants who report previous motor vehicle accidents or near-misses presumed to be
             due to excessive sleepiness while driving.

         21. Any other condition or treatment that in the opinion of the investigator could affect
             subject safety or study eligibility.