ACTIVE_NOT_RECRUITING

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

Conditions

Obstructive Sleep Apnea Hypertension Inspiratory Muscle Strength Training Blood Pressure Sleep Apnea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time-efficient Inspiratory Muscle Strength Training for Improving Blood Pressure and Vascular Function in Older Adults With Sleep Disordered Breathing

Quick Facts

Study Start:2021-09-01

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04932447

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Principal Investigator

Elizabeth F Bailey, PhD

PRINCIPAL_INVESTIGATOR

University of Arizona

Study Locations (Sites)

Arizona Respiratory and Neurophysiology Laboratory

Tucson, Arizona, 85724

United States

Collaborators and Investigators

Sponsor: University of Arizona

Elizabeth F Bailey, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-09-01

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Inspiratory Muscle Strength Training
Blood Pressure
Sleep Apnea

Additional Relevant MeSH Terms

Obstructive Sleep Apnea
Hypertension