Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea (NCT04932447) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea
United States122 participantsStarted 2021-09-01
Plain-language summary
This clinical research study will investigate the effects of respiratory strength training on blood pressure and cardiovascular health in adults who are 50 years of age and older and have been diagnosed with moderate or severe obstructive sleep apnea.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Age 50 and older
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability to provide informed consent;
* Willing to accept random assignment to condition
* AHI ≥15
* Individuals with who are unwilling or unable to adhere to CPAP
* Individuals who are adherent to CPAP therapy (i.e., 4 hours/night on 70%/nights over 30 days in the first 3 months of initial usage)
* Individuals who are adherent to mandibular advancement device each night
* Above-normal SBP (i.e., SBP ≥120)
* BMI ≤40 kg/m2
* Weight stable in the prior 3 months (\<3.0 kg weight change) and willing to remain weight stable throughout the study
* No change in anti-hypertensive medications or other medications (prescription or dosing) in the prior 3 months and willingness to maintain current medication regimen throughout the study
* Absence of unstable clinical disease as determined by medical history, physical examination, and blood chemistries
* Total cholesterol \<240 mg/dL
* Fasting plasma glucose \<300 mg/dL
Exclusion Criteria:
* Age \<50
* AHI \<15
* Individuals with central or mixed sleep disordered breathing
* Severe hypoxemia (\<80% for \>10% of recording time) during sleep
* ESS \>15
* SBP ≥160 or DBP ≥120
* Current smoker
* Chronic overt and poorly controlled medical condition (e.g., diabetes, chronic kidney disease, cancer, congestive heart failure)
* Cheyne-Stokes Respiration
* Alcohol or illegal drug dependence or abuse
* Uncon…
What they're measuring
1
Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Timeframe: Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST