Obstructive Sleep Apnea of AdultPhase 2/3NCT05009901
A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients
A Phase 2/3 study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Obstructive Sleep Apnea of Adult, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Show all 9Show fewer
- Subjects who are taking antioxidants.
- Subjects who have diabetes.
- Subjects who have autoimmune syndrome.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
UBC Hospital
Vancouver, British Columbia, V6K 2K6
Rachel Jen, rachel.jen@vch.ca
About this study
Official title: A Pilot Study of Antioxidant Therapy (Alpha Lipoic Acid, ALA) in OSA Patients
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.
Read the detailed 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.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Alpha Lipoic Acid 600 MG Oral Tablet, Placebo
- Keywords
- Obstructive Sleep Apnea, Antioxidant, Alpha Lipoic Acid, Inflammation, Endothelial Function
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 600 MG Oral TabletDrug
Also called Alpha lipoic acid
Alpha lipoic acid 600 mg daily for 8 weeks
PlaceboDrug
Placebo one tablet daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid | Experimental | alpha lipoic acid PO 600 mg daily for 8 weeks Receives: Drug: Alpha Lipoic Acid 600 MG Oral Tablet |
| Placebo | Placebo comparator | placebo PO daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of C reactive protein (CRP)
Level of circulating inflammatory marker
Measured: 8 weeks
Reactive hyperemia index (RHI)
Endothelial function measured by EndoPAT
Measured: 8 weeks
Secondary outcomes (6)
Plasma level of 8-isoprostane
Plasma level of oxidative stress marker of lipid peroxidation
Measured: 8 weeks
Plasma level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Plasma level of oxidative stress marker of DNA fragmentation
Measured: 8 weeks
Urinary level of 8-isoprostane
Level of oxidative stress marker of lipid peroxidation in urine
Measured: 8 weeks
Urinary level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Level of oxidative stress marker of DNA fragmentation in urine
Measured: 8 weeks
Telomere length
Telomere length of leukocyte
Measured: 8 weeks
Augmentation Index (AI)
Indirect measure of arterial stiffness measured by EndoPAT
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jun 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Jen, University of British Columbia
- Investigators
- Rachel Jen, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009901
- Sponsor's protocol ID
- H20-03562
- Status last verified
- May 2022
- First submitted
- 10 Aug 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Antioxidant Therapy (Alpha Lipoic Acid, ALA) in OSA Patients
- ClinicalTrials.gov ID
- NCT05009901
- Acronym / sponsor ID
- H20-03562
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Antioxidant, Alpha Lipoic Acid, Inflammation, Endothelial Function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid | Experimental | Drug: Alpha Lipoic Acid 600 MG Oral Tabletalpha lipoic acid PO 600 mg daily for 8 weeks |
| Placebo | Placebo comparator | Drug: Placeboplacebo PO daily for 8 weeks |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid 600 MG Oral TabletAlso: Alpha lipoic acidAlpha lipoic acid 600 mg daily for 8 weeks | Drug | Alpha Lipoic Acid |
| PlaceboPlacebo one tablet daily for 8 weeks | Drug | Placebo |
Primary outcome
Level of C reactive protein (CRP)
Time frame: 8 weeks
Level of circulating inflammatory marker
Reactive hyperemia index (RHI)
Time frame: 8 weeks
Endothelial function measured by EndoPAT
6 secondary outcomes
Plasma level of 8-isoprostane
Time frame: 8 weeks
Plasma level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Time frame: 8 weeks
Urinary level of 8-isoprostane
Time frame: 8 weeks
Urinary level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Time frame: 8 weeks
Telomere length
Time frame: 8 weeks
Augmentation Index (AI)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Jen, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Obstructive Sleep Apnea of Adult, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Jen, MD (6048754122, rachel.jen@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of C reactive protein (CRP) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.