A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Thioctic Acid

Criteria

Inclusion Criteria:

• Medically stable adult patients between 35 and 60 years of age with moderate to severe OSA (AHI>15 events/hour by a full night in-laboratory polysomnogram or ambulatory study)

• More than 9 minutes/night spent below oxygen saturation of 90%.

• Subjects who have declined therapy, or who have not adhered to CPAP therapy for at least one month prior to the study recruitment .

Exclusion Criteria:

• Subjects who have excessive daytime sleepiness (Epworth Sleepiness Scale > 12/24)

• Subjects who have documented CVD

• Subjects who have severe sleep associated desaturation (>30% of the sleep study with oxygen saturation <88%).

• Subjects who are on active therapy for OSA or recently treated for OSA with CPAP in the previous month.

• Subjects who have a chronic inflammatory disease (e.g. rheumatoid arthritis, asthma)

• Subjects who regularly use of anti-inflammatory drugs (i.e. systemic or inhaled corticosteroids, statin, ACEI), or other immunosuppressive drugs.

• Subjects who are taking antioxidants.

• Subjects who have diabetes.

• Subjects who have autoimmune syndrome.