A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients
-
- STATUS
- Recruiting
-
- End date
- Aug 9, 2024
-
- participants needed
- 80
-
- sponsor
- University of British Columbia
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.
Description
Purpose: To determine whether treatment of obstructive sleep apnea (OSA) patients with a potent oral antioxidant (alpha lipoic acid, ALA) improves cardiovascular health.
Objectives: The primary objective of the study is to assess the impact of ALA on endothelial function (primary outcome). We will also assess whether ALA improves systemic inflammation and markers of oxidative stress.
Background: Increased production of reactive oxygen species (ROS) and consequent oxidative stress results in tissue damage and activation of inflammation, and is a recognized risk factor for the development of cardiovascular disease (CVD). Obstructive sleep apnea (OSA) is a prevalent under-recognized disorder; moderate to severe disease is found in approximately 9% of randomly selected middle-aged men and 4% of women. In addition, patients with OSA are at increased (i.e., 3 fold) risk of incident CVD including myocardial infarction and acute coronary syndromes. OSA is characterized by repetitive episodes of desaturation followed by reoxygenation; this ischemia/reperfusion is a potent stimulus for the production of ROS, and results in high levels of oxidative stress. Indeed, OSA may be considered a prototypical oxidative stress disease. However, few studies have assessed the potential beneficial impact of antioxidant therapy in OSA patients.
We hypothesize that antioxidants may mitigate some of the adverse CV consequences associated with OSA. The current proposal builds upon our translational work, and focuses on comprehensively assessing the impact of a routinely used potent antioxidant on CV health.
Methods: 80 patients with moderate to severe OSA will be enrolled in a parallel randomized controlled trial (RCT). At baseline, endothelial function will be measured noninvasively using a standard technique (EndoPAT). In addition, we will measure circulating levels of C reactive protein, and markers of oxidative stress (urinary 8-isoprostane and 8-hydroxy-2-deoxy guanosine). Patients will be randomized to either ALA or placebo. Endothelial function and biochemical markers will be remeasured after 12 weeks to determine the impact of ALA.
If ALA does result in significant benefits, this would raise the possibility of using ALA as a therapy in OSA patients to prevent CVD, and justify a larger RCT to validate the result. This is of substantial importance given the high prevalence of OSA in the population.
Details
| Condition | Obstructive Sleep Apnea of Adult |
|---|---|
| Treatment | Placebo, Alpha Lipoic Acid 600 MG Oral Tablet |
| Clinical Study Identifier | NCT05009901 |
| Sponsor | University of British Columbia |
| Last Modified on | 9 June 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer