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Antioxidant
Antioxidant Therapy for Obstructive Sleep Apnea
Phase 2 & 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing whether antioxidants help cardiovascular health in patients with sleep apnea by reducing oxidative stress.
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.Check my eligibility
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.See study design
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 belowSelect...
My oxygen levels drop below 90% for over 9 minutes at night.
Select...
I am 35-60 years old with moderate to severe sleep apnea (AHI>15).
Select...
I have not used CPAP therapy consistently for the past month or have declined it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Level of C reactive protein (CRP)
Reactive hyperemia index (RHI)
Secondary outcome measures
Augmentation Index (AI)
Plasma level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Plasma level of 8-isoprostane
+3 moreTrial 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
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,038 Total Patients Enrolled
Rachel Jen, MDPrincipal InvestigatorUniversity of British Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I am currently taking antioxidants.I have a long-term inflammatory condition like rheumatoid arthritis or asthma.My oxygen levels drop significantly when I sleep.I have been diagnosed with cardiovascular disease.I am 35-60 years old with moderate to severe sleep apnea (AHI>15).I have not used CPAP therapy consistently for the past month or have declined it.I regularly use anti-inflammatory or immunosuppressive drugs.My oxygen levels drop below 90% for over 9 minutes at night.I am currently being treated for sleep apnea or was treated with CPAP last month.I often feel very sleepy during the day.You have an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Alpha Lipoic Acid
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05009901 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients currently signed up for this experiment?
"The clinical trial is recruiting patients, with the most recent update to the posting on clinicaltrials.gov being on 5/18/2022. This study was first posted on 6/1/2022."
Answered by AI
Are there any other similar tests that have been done with Alpha Lipoic Acid 600 MG Oral Tablet?
"To date, there have been 9 clinical trials evaluating the effects of Alpha Lipoic Acid 600 MG Oral Tablet. One of these studies is currently in Phase 3. Most of the research for Alpha Lipoic Acid 600 MG Oral Tablet is based in Aurora, Colorado; however, there are 19 total locations running these trials."
Answered by AI
How can I sign up to be a research subject in this investigation?
"To be eligible for this apnea trial, patients must be aged 35 to 60. So far, 80 people have been recruited for the study."
Answered by AI
What medical conditions does Alpha Lipoic Acid 600 MG Oral Tablet help to alleviate?
"Alpha Lipoic Acid 600 MG Oral Tablet is useful in the treatment of diabetic neuralgia, nutritional supplementation, and dietary and nutritional therapies."
Answered by AI
Are elderly individuals welcome in this clinical trial?
"The age requirement to enroll in this particular trial is between 35 to 60 years old. In contrast, there are 50 clinical trials that have a lower age limit of 18 years old and 254 trials that have an upper age limit of 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Maryland
How old are they?
18 - 65
65+
What site did they apply to?
UBC Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried everything h and Ala seems to help.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- UBC Hospital: < 48 hours
Average response time
- < 2 Days
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