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Behavioral Intervention
Breathing Training for Sleep Apnea
N/A
Recruiting
Led By Elizabeth F Bailey, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to understand study procedures and to comply with them for the entire length of the study
Age 50 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst
Awards & highlights
Study Summary
This trial will study whether respiratory strength training can help improve blood pressure and cardiovascular health in adults 50+ with moderate or severe obstructive sleep apnea.
Who is the study for?
Adults aged 50+ with moderate to severe obstructive sleep apnea, who don't use CPAP or are adherent to alternative treatments like mandibular devices. Participants should have stable weight and medication regimens, no recent drug abuse, and be free from unstable diseases. They must have a BMI ≤40 kg/m^2, blood pressure ≥120/≤160 mmHg, cholesterol <240 mg/dL, fasting glucose <300 mg/dL.Check my eligibility
What is being tested?
The trial is testing Inspiratory Muscle Strength Training (IMST) to see if it can improve blood pressure and cardiovascular health in older adults with obstructive sleep apnea. Participants will be randomly assigned to either undergo IMST or not as part of the study.See study design
What are the potential side effects?
While specific side effects of IMST aren't detailed here, potential risks may include discomfort during training exercises or fatigue due to increased respiratory effort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can follow the study's procedures.
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I am 50 years old or older.
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My weight has been stable for the last 3 months and I can keep it stable during the study.
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I cannot or will not use CPAP for my condition.
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I use my CPAP machine regularly, at least 4 hours a night.
Select...
I use my CPAP machine regularly, at least 4 hours a night for most nights.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Secondary outcome measures
Change from baseline 24-hour Ambulatory Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Change from baseline Plasma Norepinephrine at 24 weeks, 28 weeks, and 36 weeks
Other outcome measures
Change from Baseline 24-hour Ambulatory Diastolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Diastolic blood pressure
Change from Baseline Grip Strength at 24 weeks, 28 weeks, and 36 weeks
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Training Group AExperimental Treatment1 Intervention
Participants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device.
Group II: Training Group BPlacebo Group1 Intervention
Participants will perform their respiratory training (low-intensity, low-volume IMST) on a hand-held respiratory training device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inspiratory Muscle Strength Training
2013
N/A
~40
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,092 Total Patients Enrolled
University of ArizonaLead Sponsor
517 Previous Clinical Trials
148,381 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,105 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed my blood pressure or any other medications in the last 3 months and am willing to keep them the same during the study.I understand and can follow the study's procedures.I am 50 years old or older.You weigh less than 40 kilograms for every meter of your height.Your score on the ESS (Epworth Sleepiness Scale) is higher than 15.I have a long-term health condition like diabetes or heart failure that is not well-managed.My weight has been stable for the last 3 months and I can keep it stable during the study.You have an Apnea-Hypopnea Index (AHI) of less than 15.You have severe sleep apnea with an AHI score of 15 or higher.I cannot or will not use CPAP for my condition.Your total cholesterol level is less than 240 mg/dL.Your blood pressure is higher than 160/120.You have severe low oxygen levels during sleep for a significant amount of time.I am under 50 years old.My overall health is stable according to recent exams and blood tests.You have a problem with drinking too much alcohol or using illegal drugs.Your blood sugar level while fasting should be less than 300 mg/dL.I experience a specific pattern of breathing that speeds up and slows down.I have a sleep disorder that affects my breathing.You regularly do intense aerobic exercise for more than 30 minutes at a time, at least 4 times a week.You use the mandibular advancement device every night.You are currently smoking cigarettes.My thyroid condition is stable, and I haven't changed my medication in the last 3 months.I use my CPAP machine regularly, at least 4 hours a night.Your blood pressure is higher than normal (120 or above).I use my CPAP machine regularly, at least 4 hours a night for most nights.
Research Study Groups:
This trial has the following groups:- Group 1: Training Group A
- Group 2: Training Group B
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.
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