CPAP to Treat Cognitive Dysfunction in MS

This is an interventional other trial for Multiple Sclerosis focused on measuring OSA, Obstructive Sleep Apnea, Cognition, Cognitive Dysfunction, Memory, Positive Aiway Pressure, CPAP, MS Read More

Inclusion Criteria

1. Age of 18-70 years at screening
2. Diagnosis of clinically definite MS
3. Willingness to undergo in-lab baseline polysomnography (PSG) and positive airway pressure (PAP) titration (if needed)
4. Willingness to undergo 2 separate 90-minute cognitive testing sessions

5. Either one of the following:

   Score of >=2 sleep apnea risk factors on the "STOP-Bang" sleep apnea screening questionnaire. The STOP-Bang questionnaire is a screening tool consisting of eight items which reflect OSA risk factors. STOP-Bang scores of ≥3 indicate elevated risk for moderate-severe OSA in the general population, and scores as low as 2 are frequently seen in MS patients with OSA, based on previous data from the PI).

   OR

   Have a pre-existing diagnosis of OSA based on a previous overnight sleep study (either home study or in-lab) but have not yet started using PAP therapy on a compliant basis. *If OSA was NOT diagnosed by a U-M in-lab sleep study within the past year prior to screening, subjects must be willing to get new baseline in-lab U-M PSG as part of study.

6. Willingness to start treatment with PAP if OSA present

Exclusion Criteria

1. Physical, psychiatric or cognitive impairment that prevents informed consent, PSG, PAP use, or reliable longitudinal follow-up
2. Cardiopulmonary conditions that may increase sleep apnea risk
3. Current treatment, such as PAP, for obstructive or central sleep apnea
4. History of surgical treatment for OSA
5. Nervous system diseases other than MS that may predispose subjects to OSA (such as Parkinson's disease, amyotrophic lateral sclerosis, or recent stroke)
6. History of concomitant central nervous system disease that could influence cognition, such as large vessel territory stroke, Alzheimer's disease, Parkinson's disease, or Lewy body dementia
7. Concomitant systemic autoimmune disease with secondary central nervous system involvement (including CNS lupus or neurosarcoidosis).
8. Pregnancy
9. Evidence of clinical MS relapse within the last 30 days prior to enrollment
10. Systemic high dose steroid use (1 gram IV methylprednisolone daily for 3-5 days or equivalent)for an MS relapse within the last 30 days prior to enrollment
11. Unwillingness to initiate PAP therapy if clinically indicated
12. Severe depression at screening per the Patient Health Questionnaire-8 (PHQ-8) (The PHQ-8 is a brief, self-administered questionnaire that evaluates core symptoms associated with major depressive disorder. Scores range from 0 to 24 based on the frequency and severity of depressive symptoms over the previous two weeks.)
13. Anticipated initiation, dosage change, or discontinuation in medications that could, per the opinion of the investigators, influence cognitive test scores from baseline to follow-up, including MS disease modifying therapies, hypnotic agents, narcotic-based medications, benzodiazepines, antispasmodics, or 4-aminopyridine
14. ESS scores >= 16 on baseline visit
15. Subjects with extreme OSA accompanied by signs of cardiopulmonary compromise (RDI>60 respiratory events per hour with severe nocturnal hypoxia or unstable ECG rhythms on PSG), will be excluded unless they are randomized to immediate PAP arm
16. Any other condition or treatment that in the opinion of the investigator could affect subject safety or study eligibility