CPAP to Treat Cognitive Dysfunction in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The objectives of this study are to determine the effects of obstructive sleep apnea (OSA) on
      cognitive function in patients with multiple sclerosis (MS); and to evaluate whether OSA
      treatment with positive airway pressure therapy could improve cognitive dysfunction in MS
      patients who have OSA.
    

Detailed description: 
      Up to 70% of patients with MS suffer from cognitive dysfunction (difficulties with thinking,
      information processing, verbal expression, or memory). Cognitive dysfunction is one of the
      most disabling symptoms of MS, that can profoundly affect job performance, family
      responsibilities, and quality of life. While no treatments have been shown to improve
      cognitive dysfunction in MS, many patients have not been evaluated or treated for other
      common health problems that could be contributing to their cognitive dysfunction.

      Up to 50% of MS patients also suffer from obstructive sleep apnea (OSA). Obstructive sleep
      apnea is a common disorder in which the upper airway collapses during sleep, causing poor
      sleep quality and decreased oxygen levels in the blood. In patients without MS, OSA is a
      well-established cause of poor cognitive performance. Recent studies of non-MS patients also
      suggest that cognitive performance may improve with OSA treatment. Yet, despite the high
      number of MS patients with OSA, the relationship between OSA and cognitive performance, and
      the effects of OSA treatment on cognitive performance in MS, has not received sufficient
      study.

      The objectives of this study are to determine the effects of obstructive sleep apnea (OSA) on
      cognitive function in patients with multiple sclerosis (MS); and to evaluate whether OSA
      treatment with positive airway pressure therapy could improve cognitive dysfunction in MS
      patients who also have OSA.

      Interested participants with MS who screen positive on a commonly used screening tool used to
      detect those at high risk for OSA will be invited to participate. Consenting participants
      will have a baseline cognitive (memory and thinking) test to assess their cognitive function,
      and an overnight sleep study (polysomnogram, or PSG) to determine if they have obstructive
      sleep apnea. If the sleep study shows signs of sleep apnea, participants will be assigned
      treatment for their sleep apnea with positive airway pressure (PAP) therapy, either
      immediately (Group 1), or 3 months after the baseline sleep study (Group 2). Groups will be
      assigned at random (like flipping a coin). There is a 2/3 chance that participants will be
      assigned to Group 1. PAP therapy is considered standard clinical care for OSA. It involves
      wearing an apparatus that includes a hose and a mask (that covers the nose, or nose and
      mouth), connected to a small machine that blows air into the airway during sleep. In order to
      determine which airway pressure most effectively treats an individual's sleep apnea, and what
      type of mask is needed, a separate sleep study known as an overnight "PAP titration study"
      will also be performed. This study is similar to a PSG but also involves fitting of various
      masks which are then hooked up to the individual and PAP machine to test the effectiveness of
      various PAP settings, and to determine which mask is most tolerable for the individual.

      Participants will also receive repeat cognitive testing at 3 months to see if the immediate
      sleep apnea treatment group (Group 1) shows improvements memory and thinking, as compared to
      the standard care treatment group (Group 2), who will not start apnea treatment until after
      their repeat cognitive test. Participants will be compensated for their travel and time
      throughout the course of the study.
    

Intervention name(s): PAP therapy
Intervention type(s): Device
Intervention description(s): Positive airway pressure treatment for obstructive sleep apnea
Other intervention name(s): Positive airway pressure; CPAP; BiPAP; Continuous positive airway pressure; Bi-level positive airway pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: OSA; Obstructive Sleep Apnea; Cognition; Cognitive Dysfunction; Memory; Positive Aiway Pressure; CPAP; MS