Recruiting
Phase 2
Phase 3

Antioxidant Therapy

Sponsor:

University of British Columbia

Code:

NCT05009901

Conditions

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Not accepted

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet

Placebo

Study Details

Brief 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.

Conditions

Obstructive Sleep Apnea of Adult

Study ID

NCT05009901

Start date

Jun 1, 2022

Status verified date

May, 2022

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alpha Lipoic Acid

alpha lipoic acid PO 600 mg daily for 8 weeks

placebo comparator: Placebo

placebo PO daily for 8 weeks

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet

Alpha lipoic acid 600 mg daily for 8 weeks

Placebo

Placebo one tablet daily for 8 weeks

Primary outcome measure

  • Level of C reactive protein (CRP) [ Time Frame: 8 weeks ]
  • Reactive hyperemia index (RHI) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

UBC Hospital

Recruiting

Vancouver, British Columbia, Canada, V6K 2K6

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

May 25, 2022

Last verified

May, 2022

Keywords

  • Obstructive Sleep Apnea
  • Antioxidant
  • Alpha Lipoic Acid
  • Inflammation
  • Endothelial Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-05-25.