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Mild Intermittent Hypoxia for Obstructive Sleep Apnea
Phase 1 & 2
Recruiting
Led By Jason H Mateika, PhD MS BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female of any race, 30-60 years of age with a BMI of less than 40 kg/m2 and a weight to hip ratio of less than 1.3in males and 1.2 in females along with pure or predominantly (i.e., comprised of both a central and obstructive component)OSA (AHI less than or equal to 100 events per hour and an average oxygen desaturation level of 85 % or greater).
All participants will have normal lung function and a normal EKG with no or minimal alcohol consumption (< 2 oz of alcohol/night).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change at 15 days, 4 and 8-weeks following treatment compared to baseline
Awards & highlights
Study Summary
This trial will study if repeated exposure to mild intermittent hypoxia (MIH) can reduce heart and blood vessel dysfunction and tiredness/fatigue experienced while exercising for people with obstructive sleep apnea (OSA).
Who is the study for?
This trial is for adults aged 30-60 with a BMI under 40, newly diagnosed obstructive sleep apnea (OSA), and hypertension. They must have normal lung function, EKG readings, controlled alcohol intake, and not be on CPAP treatment or multiple medications. Pre-diabetic individuals with specific cholesterol levels can join too.Check my eligibility
What is being tested?
The study tests whether mild intermittent hypoxia (MIH) can improve heart health and reduce fatigue during exercise in OSA patients by increasing airway stability and enhancing sleep quality. It compares MIH to a sham procedure to see if it's an effective standalone or adjunct therapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the hypoxia exposure or placebo effect from the sham procedure. The intervention aims to be minimally invasive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 30-60 years old, with a BMI under 40, and have sleep apnea with specific measurements.
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My lungs work normally, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol nightly.
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I have never used a CPAP machine before.
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I have never used CPAP for my condition before.
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I am between 30-60 years old, with a BMI under 40, and have sleep apnea with specific severity.
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My lung function is normal, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol per night.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change at 15 days, 4 and 8- weeks following treatment compared to baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change at 15 days, 4 and 8- weeks following treatment compared to baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Blood Pressure
Hyperemia
Change in Microvascular Function (Time to reach Maximal Hyperemic Response)
Secondary outcome measures
Change in Fatigability
Change in Maximal Oxygen Consumption
Body Weight Changes
+4 moreOther outcome measures
Change in Arousal Threshold
Continuous Positive Airway Pressure
Change in Sleep Apnea Severity
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mild Intermittent Hypoxia (MIH)Experimental Treatment1 Intervention
This arm of the protocol will receive mild intermittent hypoxia (8% oxygen) with end-tidal carbon dioxide maintained 2 millimeters of mercury above baseline, while in the laboratory.
Group II: Sham Mild Intermittent Hypoxia (Sham MIH)Placebo Group1 Intervention
This arm of the protocol will receive sham MIH (the equivalent of room air), while in the laboratory.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,124 Total Patients Enrolled
John D. Dingell VA Medical CenterFED
8 Previous Clinical Trials
716 Total Patients Enrolled
Jason H Mateika, PhD MS BSPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known disease such as pulmonary hypertension.I am only on one medication for high blood pressure that's hard to control.My lung function is normal, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol per night.My lungs work normally, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol nightly.I have never used a CPAP machine before.I have never used CPAP for my condition before.I am between 30-60 years old, with a BMI under 40, and have sleep apnea with specific severity.I am pre-diabetic with specific blood sugar and cholesterol levels.My menstrual cycle will be tracked for this study.I am 30-60 years old, with a BMI under 40, and have sleep apnea with specific measurements.I have high blood pressure that is not well-controlled with one medication.I am pre-diabetic with specific blood sugar and cholesterol levels.If your blood pressure is consistently higher than 160/110, you cannot take part in the study.I use sleep aids like melatonin.You work at night or have recently traveled across different time zones.My menstrual cycle will be tracked for this study.I have high blood pressure that is not well-controlled with one medication.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Intermittent Hypoxia (MIH)
- Group 2: Sham Mild Intermittent Hypoxia (Sham MIH)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with certain medical conditions able to participate in this research project?
"The clinical trial described is not presently looking for participants, based on the most recent update to their information on clinicaltrials.gov (9/27/2022). However, there are currently 475 other trials that are actively recruiting patients."
Answered by AI
What goals does this scientific research aim to achieve?
"The goal of this clinical trial is to observe the change in blood pressure over a period of 15 days, 4 weeks, and 8 weeks following treatment. Secondary outcomes that will be monitored include change in fatigability (as measured by a 10-minute walk test), change in muscle oxygen extraction (mean response time and tau), and changes in other markers."
Answered by AI
Will this research be conducted with elderly individuals?
"This specific trial is only seeking patients that are aged between 30-60. However, there are other ongoing clinical trials for minors and elderly citizens."
Answered by AI
Would I be able to help out with this medical research?
"Eligible patients for this sleep apnea study must be between 30 and 60 years old with a diagnosis of obstructive sleep apnea. Sixty total participants will be accepted into the clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
John D. Dingell VA Medical Center, Detroit, MI
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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