Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea

NCT04932447 | Active Not Recruiting DMC

• 2 other identifiers: 12000002201R01AG065346-01A1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Hypertension

Keywords

Inspiratory Muscle Strength Training; Blood Pressure; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

  The primary endpoint is casual (resting) systolic blood pressure (SBP) measured by both relative and absolute changes from baseline. SBP will be assessed in accordance with American College of Cardiology/American Heart Association guidelines. Measurements will be taken using an automated oscillometric sphygmomanometer and will be performed in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between measures. SBP will be defined as the average of the 3 pressures.

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

Secondary Outcomes (2)

• Change from baseline 24-hour Ambulatory Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

• Change from baseline Plasma Norepinephrine at 24 weeks, 28 weeks, and 36 weeks

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

Other Outcomes (13)

• Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD) and suppression of EDD by oxidative stress at 24 weeks, 28 weeks, and 36 weeks

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

• Change from baseline Carotid-Femoral Pulse Wave Velocity at 24 weeks, 28 weeks, and 36 weeks

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

• Change from baseline vasoconstrictor factors at 24 weeks, 28 weeks, and 36 weeks

  Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST

Study Arms (2)

Training Group A

EXPERIMENTAL

Participants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device.

Behavioral: Inspiratory Muscle Strength Training

Training Group B

SHAM COMPARATOR

Participants will perform their respiratory training (low-intensity, low-volume IMST) on a hand-held respiratory training device.

Behavioral: Inspiratory Muscle Strength Training

Interventions

Inspiratory Muscle Strength Training BEHAVIORAL

30 breaths/ day, 5 days/week for 24 weeks.

Training Group A; Training Group B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

Arizona Respiratory and Neurophysiology Laboratory

Tucson, Arizona, 85724, United States

Location

Related Publications (6)

• DeLucia CM, DeBonis DR, Schwyhart SM, Bailey EF. Acute cardiovascular responses to a single bout of high intensity inspiratory muscle strength training in healthy young adults. J Appl Physiol (1985). 2021 Apr 1;130(4):1114-1121. doi: 10.1152/japplphysiol.01015.2020. Epub 2021 Feb 18.

  PMID: 33600284 BACKGROUND

• Ramos-Barrera GE, DeLucia CM, Bailey EF. Inspiratory muscle strength training lowers blood pressure and sympathetic activity in older adults with OSA: a randomized controlled pilot trial. J Appl Physiol (1985). 2020 Sep 1;129(3):449-458. doi: 10.1152/japplphysiol.00024.2020. Epub 2020 Jul 30.

  PMID: 32730174 BACKGROUND

• DeLucia CM, De Asis RM, Bailey EF. Daily inspiratory muscle training lowers blood pressure and vascular resistance in healthy men and women. Exp Physiol. 2018 Feb 1;103(2):201-211. doi: 10.1113/EP086641. Epub 2018 Jan 15.

  PMID: 29178489 BACKGROUND

• Vranish JR, Bailey EF. Inspiratory Muscle Training Improves Sleep and Mitigates Cardiovascular Dysfunction in Obstructive Sleep Apnea. Sleep. 2016 Jun 1;39(6):1179-85. doi: 10.5665/sleep.5826.

  PMID: 27091540 BACKGROUND

• Vranish JR, Bailey EF. Daily respiratory training with large intrathoracic pressures, but not large lung volumes, lowers blood pressure in normotensive adults. Respir Physiol Neurobiol. 2015 Sep 15;216:63-9. doi: 10.1016/j.resp.2015.06.002. Epub 2015 Jun 22.

  PMID: 26112283 BACKGROUND

• Tavoian D, Ramos-Barrera LE, Craighead DH, Seals DR, Bedrick EJ, Alpert JS, Mashaqi S, Bailey EF. Six Months of Inspiratory Muscle Training to Lower Blood Pressure and Improve Endothelial Function in Middle-Aged and Older Adults With Above-Normal Blood Pressure and Obstructive Sleep Apnea: Protocol for the CHART Clinical Trial. Front Cardiovasc Med. 2021 Nov 24;8:760203. doi: 10.3389/fcvm.2021.760203. eCollection 2021.

  PMID: 34901220 DERIVED

Related Links

• Pre-screening questionnaire for interested participants

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elizabeth F Bailey, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a randomized double-blinded clinical trial.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly allocated using a 1:1 ratio to A) High-Intensity Training Group (75 % maximal inspiratory pressure) or B)Low-Intensity Training Group (15% maximal inspiratory pressure)

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 21, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)