What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, oral appliances, and surgical interventions. CPAP therapy can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Oral appliances may lead to jaw discomfort, dry mouth, and excessive salivation. Surgical treatments can result in pain, swelling, and infection risks. Antioxidant therapy, aimed at reducing oxidative stress, is being studied for its potential benefits in OSA patients. While specific side effects of antioxidant therapy in OSA are not well-documented, general side effects of antioxidants can include gastrointestinal discomfort, headaches, and allergic reactions.

What prior FDA approvals exist?

Currently, the FDA has approved treatments for Obstructive Sleep Apnea (OSA) that primarily include Continuous Positive Airway Pressure (CPAP) devices, oral appliances like mandibular advancement devices, and surgical interventions. While antioxidant therapy aimed at reducing oxidative stress is being studied for its potential benefits in OSA patients, it has not yet received FDA approval specifically for this condition. The ongoing research aims to determine if antioxidants can improve cardiovascular health by reducing oxidative stress in OSA patients.

What other types of research exist?

Promising novel alternatives to antioxidants for reducing oxidative stress in obstructive sleep apnea patients include: 1) Continuous Positive Airway Pressure (CPAP) therapy, which remains the gold standard for managing OSA and reducing oxidative stress by preventing airway collapse. 2) Mandibular advancement devices (MADs), which help keep the airway open and reduce oxidative stress. 3) Lifestyle modifications such as weight loss, exercise, and dietary changes, which can improve OSA symptoms and reduce oxidative stress. 4) Pharmacological treatments targeting specific pathways involved in oxidative stress and inflammation, such as anti-inflammatory drugs or agents targeting reactive oxygen species. 5) Emerging therapies like hypoglossal nerve stimulation, which helps maintain airway patency and may reduce oxidative stress.

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Antioxidant

Antioxidant Therapy for Obstructive Sleep Apnea

Phase 2 & 3

Waitlist Available

Led By Rachel Jen, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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)

Must not have

Subjects who have diabetes.

Subjects who are taking antioxidants.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial tests whether an antioxidant called alpha lipoic acid (ALA) can improve heart health in adults with moderate to severe sleep apnea. Sleep apnea causes breathing problems during sleep and increases the risk of heart disease. ALA may help by reducing harmful substances that damage blood vessels and cause inflammation. Alpha lipoic acid (ALA) is a potent antioxidant with anti-inflammatory properties.

Who is the study for?

Adults aged 35-60 with moderate to severe obstructive sleep apnea, who haven't adhered to CPAP therapy and spend over 9 minutes a night with low oxygen levels. Excluded are those with autoimmune diseases, excessive daytime sleepiness, cardiovascular disease, recent OSA treatment, diabetes, chronic inflammatory diseases or on anti-inflammatory/immunosuppressive drugs.

What is being tested?

The study tests if antioxidants (Alpha Lipoic Acid) improve heart health in sleep apnea patients by comparing it against a placebo. Participants will be randomly assigned to either the antioxidant or placebo group without knowing which one they're taking and monitored for blood vessel function and cardiac risk markers.

What are the potential side effects?

While not specified in the provided information, common side effects of Alpha Lipoic Acid may include skin rash, muscle cramp, headache or tingling sensation; however these vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My oxygen levels drop below 90% for over 9 minutes at night.

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I am 35-60 years old with moderate to severe sleep apnea (AHI>15).

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I have not used CPAP therapy consistently for the past month or have declined it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I am currently taking antioxidants.

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I have a long-term inflammatory condition like rheumatoid arthritis or asthma.

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My oxygen levels drop significantly when I sleep.

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I have been diagnosed with cardiovascular disease.

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I often feel very sleepy during the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Level of C reactive protein (CRP)

Reactive hyperemia index (RHI)

Secondary study objectives

Augmentation Index (AI)

Plasma level of 8-hydroxy-2-deoxy guanosine (8-OHdG)

Plasma level of 8-isoprostane

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Alpha Lipoic AcidExperimental Treatment1 Intervention

alpha lipoic acid PO 600 mg daily for 8 weeks

Group II: PlaceboPlacebo Group1 Intervention

placebo PO daily for 8 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpha Lipoic Acid 600 MG Oral Tablet

2023

N/A

~60

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Obstructive Sleep Apnea (OSA) is commonly treated with Continuous Positive Airway Pressure (CPAP) therapy, which keeps the airway open during sleep, and lifestyle changes such as weight loss. Another emerging treatment involves the use of antioxidants to reduce oxidative stress. OSA causes repetitive airway collapse, leading to intermittent hypoxia and reoxygenation, which generates reactive oxygen species (ROS) and contributes to oxidative stress. This oxidative stress is linked to cardiovascular complications in OSA patients. Antioxidants help neutralize ROS, potentially improving cardiovascular health and reducing inflammation and oxidative damage. This approach is being studied to determine its efficacy in improving blood vessel function and reducing cardiac risk markers in OSA patients.

Chronic intermittent hypoxia impaired collagen synthesis in mouse genioglossus via ROS accumulation: A transcriptomic analysis.Protective effects of mitochondria-targeted antioxidants and statins on cholesterol-induced osteoarthritis.Oxidative stress in obstructive sleep apnea and intermittent hypoxia--revisited--the bad ugly and good: implications to the heart and brain.