Intervention: DIMETHYL FUMARATE
Trial phase: Phase 2
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.

Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose.
Eligibility criteria:
Inclusion Criteria:

Age of 18-65 years at screening;
Diagnosis of OSA as confirmed by previous clinical sleep study (polysomnography, PSG);
Refusal, inability, or high reluctance to use CPAP regularly for treatment of OSA, despite medical advice;
Willingness to undergo repeat sleep study (PSG) and blood studies;
Normal immune cell counts, as evidenced by complete blood count (CBC) done at screening

Exclusion Criteria:

Regular use of CPAP within the last 2 months
Physical, psychiatric or cognitive impairment that prevents informed consent, PSG, or reliable follow-up;
Cardiac conditions that may increase sleep apnea severity (e.g., congestive heart failure or recent heart attack);
Current successful treatment for obstructive or central sleep apnea, for example by CPAP, and patient agreement to continue with that treatment;
History of surgical treatment for OSA within past 6 months, or subsequent to last PSG confirmation that OSA is present;
Active nervous system diseases that may predispose subjects to OSA;
Systemic autoimmune disease that could increase inflammation and influence apnea severity (such as rheumatoid arthritis or lupus);
Pregnancy or breastfeeding;
Use of immunotherapies or immunosuppressants, currently or within past 6 months;
Anticipated initiation or dose change in tricyclic antidepressants, selective serotonin uptake inhibitors, or related compounds;
Participants with a history of active, serious or persistent infections.
Participants with recent surgery (within 3 months prior to screening), or anticipated surgery during the length of the study.
Systemic steroid use within the last 2 months (does not include local steroid injections or intranasal steroid spray);
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;
History of a lymphoproliferative disorder (such as leukemia);
History of Multiple Myeloma
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.
Refusal to use at least one reliable method of birth control (for women of childbearing age)
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)
Participants who report previous motor vehicle accidents or near-misses presumed to be due to excessive sleepiness while driving.
Any other condition or treatment that in the opinion of the investigator could affect subject safety or study eligibility.