A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients

NCT05009901 | Unknown Phase 2

• 1 other identifier: H20-03562
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Level of C reactive protein (CRP)

  Level of circulating inflammatory marker

  8 weeks

• Reactive hyperemia index (RHI)

  Endothelial function measured by EndoPAT

  8 weeks

Secondary Outcomes (6)

• Plasma level of 8-isoprostane

  8 weeks

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

  8 weeks

• Urinary level of 8-isoprostane

  8 weeks

• Urinary level of 8-hydroxy-2-deoxy guanosine (8-OHdG)

  8 weeks

• Telomere length

  8 weeks

Study Arms (2)

Alpha Lipoic Acid

EXPERIMENTAL

alpha lipoic acid PO 600 mg daily for 8 weeks

Drug: Alpha Lipoic Acid 600 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

placebo PO daily for 8 weeks

Drug: Placebo

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet DRUG

Alpha lipoic acid 600 mg daily for 8 weeks

Also known as: Alpha lipoic acid

Alpha Lipoic Acid

Placebo DRUG

Placebo one tablet daily for 8 weeks

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Hospital

Vancouver, British Columbia, V6K 2K6, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation

Interventions

Thioctic Acid; Tablets

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rachel Jen, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Jen, MD

CONTACT

6048754122; rachel.jen@vch.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: June 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)