Dimethyl Fumarate for Obstructive Sleep Apnea

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Dimethyl Fumarate

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.