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Mild Intermittent Hypoxia for Sleep Apnea
N/A
Waitlist Available
Led By Jason H Mateika, Ph.D.
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and 15 of the protocol
Awards & highlights
Study Summary
This trial will investigate whether exposure to mild intermittent hypoxia (IH) can help reduce the severity of sleep apnea and its associated comorbidities.
Eligible Conditions
- Obstructive Sleep Apnea
- Spinal Cord Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and 15 of the protocol
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and 15 of the protocol
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 measured during quiet wakefulness over the 24 hour period following mild intermittent hypoxia and sham protocol
Secondary outcome measures
Change in angiogenic/vasculogenic biomarkers following mild intermittent hypoxia and sham protocol
Change in attention following mild intermittent hypoxia and sham protocol
Change in beat to beat measures of blood pressure following mild intermittent hypoxia and sham protocol
+10 moreOther outcome measures
Change in CPAP treatment adherence following mild intermittent hypoxia and sham protocol
Change in therapeutic pressure following mild intermittent hypoxia and sham protocol
Change in upper airway collapsibility following mild intermittent hypoxia and sham protocol
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment2 Interventions
The experimental group is comprised of participants with OSA and hypertension [either able bodied (Aim 1) or with spinal cord injury (Aim 2)] that will be treated with mild IH and CPAP. In the present proposal, the mild IH protocol will be administered during wakefulness each day for 15 days over a 3-week period to participants that will also be treated with CPAP during sleep. The mild IH protocol will be comprised of a 20-minute baseline period followed by exposure to twelve - two minute episodes of hypoxia [partial pressure of end-tidal oxygen (PETO2) = 50 mmHg]. Each episode will be interspersed with a 2-minute recovery period under normoxic conditions. The PETCO2 will be sustained 2 mmHg above baseline values for the last ten minutes of baseline and throughout the remainder of the protocol.
Group II: Control GroupPlacebo Group2 Interventions
The control group is comprised of hypertensive OSA participants [either able bodied (Aim 1) or with spinal cord injury (Aim 2)] that will be exposed to a sham protocol in addition to being treated with CPAP during sleep. The sham protocol will be administered during wakefulness for 15 days over a 3-week period. During the sham protocol the participants will be exposed to atmospheric levels of oxygen and carbon dioxide for the duration of the protocol.
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Who is running the clinical trial?
Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,424 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,456 Total Patients Enrolled
Jason H Mateika, Ph.D.Principal Investigator - Wayne State University
Wayne State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index is less than 40.You have a medical condition other than high blood pressure and sleep apnea.You are taking medications for high blood pressure or sleep aids like melatonin.You use a CPAP machine for at least 4 hours every night.You are between 18 and 60 years old.You work at night or have recently traveled across different time zones.You have just been diagnosed with sleep apnea and have not started treatment for it.You have been diagnosed with prehypertension or Stage 1 hypertension according to the American Heart Association.Your lungs must work normally.You can only drink a small amount of alcohol, like one glass of wine per day.If you have a spinal cord injury and it's been more than 3 years, you can't join the study if you have certain types of movement or lack of movement in your legs.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group
- Group 2: Control Group
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.
Does this experiment only allow individuals under 35 years old to participate?
"The age limit for this clinical study is 60 years old. All participants must be at least 18 years of age."
Answered by AI
Could I join the ranks of those being helped by this research?
"This trial is open to 40 individuals that have recently suffered a spinal cord injury and meet the following conditions: being between 18-60 years old, having a body mass index under 40 kg/m^2, having undiagnosed sleep apnea with an apnea/hypopnea index of less than 100 events per hour, being diagnosed with prehypertension or Stage 1 hypertension, not being pregnant, having normal lung function, consuming minimal amounts of alcohol, having a typical sleep schedule, and for spinal cord injured participants (Aim-2): having an incomplete spinal cord lesion at C3 or below and above T12 ("
Answered by AI
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