Breathing training to improve heart health in older adults with sleep apnea
Time-efficient Inspiratory Muscle Strength Training for Improving Blood Pressure and Vascular Function in Older Adults With Sleep Disordered Breathing
This study is testing if a daily breathing exercise can help lower blood pressure and improve heart health in older adults with sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT04932447 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 50 and older with a diagnosis of moderate to severe obstructive sleep apnea and elevated blood pressure.
Not a fit: Patients who are adherent to continuous positive airway pressure (CPAP) therapy or those with unstable clinical diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a simple and effective method for lowering blood pressure and improving cardiovascular health in older adults with sleep apnea.
How similar studies have performed: Previous studies have shown promising results with inspiratory muscle strength training in reducing blood pressure, indicating potential success for this approach in the targeted population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.