A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
Sleep apnea is a common under-diagnosed medical disorder, and moderate to severe disease is
found in approximately 9% of men and 4% of women. The disease is characterized by repetitive
collapse of the airway during sleep, causing sleep disruption, episodic low oxygen levels,
and daytime sleepiness. Also, patients with sleep apnea are at high risk of developing
cardiovascular disease (including strokes and heart attacks). Partly, this is because the
episodic low oxygen levels followed by higher oxygen levels due to sleep apnea results in the
generation of reactive oxygen species (unstable and potentially toxic substances caused by
interactions with oxygen) and a state of "oxidative stress." Oxidative stress is an important
contributing factor to heart disease. We are interested in determining whether treatment with
antioxidants, which are substances that help reduce oxidative stress, helps cardiovascular
health in patients with sleep apnea. Specifically, we want to determine whether treatment
improves blood vessel function (an early sign of heart disease), and blood/urine markers of
cardiac risk (i.e., inflammation and oxidative stress).
Eighty adult patients with moderate to severe sleep apnea will be asked to participate. They
will have their blood vessel function measured with a non-invasive finger probe, and
blood/urine will be collected to measure the cardiac risk markers. Patients will then be
'randomized' to one of two groups: 50% chance that the patient will be asked to take an
antioxidant, and a 50% chance that they will be asked to take a placebo tablet (though he/she
will not know which one they are taking). After 8 weeks, blood vessel function and markers
will be remeasured to determine if antioxidants help patients with sleep apnea.