Breathing training to improve heart health in older adults with sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical research investigates the effects of inspiratory muscle strength training (IMST) on blood pressure and cardiovascular health in adults aged 50 and older diagnosed with moderate to severe obstructive sleep apnea. The study aims to determine if a simple daily regimen of IMST can significantly lower resting systolic blood pressure and improve cardiovascular outcomes. By targeting older adults with obstructive sleep apnea, the research addresses a growing health concern linked to hypertension and cardiovascular disease. Preliminary data suggest that even a short duration of IMST can lead to meaningful reductions in blood pressure and sympathetic nervous system activity.

Why it matters

Who can join: the full rules

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
* Uncontrolled thyroid disease or change in thyroid medication within previous 3 months
* Regular/vigorous aerobic exercise (\> 4 bouts/week, \>30 min/bout at high workload \>6 METS)

Where it's running

• Arizona Respiratory and Neurophysiology Laboratory
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: Elizabeth F Bailey, PhD — University of Arizona
• Study coordinator: Adrielle Barcibal, BS
• Email: abarcibal@arizona.edu
• Phone: 5206260836

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of Obstructive Sleep Apnea in Hypertensive Patients in China

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• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

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• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

  This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.

  Recruiting E-DA Hospital · Kaohsiung City · NCT07921329

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.