Obstructive Sleep ApneaNCT04932447
Breathing Training for Improving Cardiovascular Health in Older Adults With Sleep Apnea
A study testing Inspiratory Muscle Strength Training in people with Obstructive Sleep Apnea and Hypertension, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- Inspiratory Muscle Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Respiratory and Neurophysiology Laboratory
Tucson, Arizona, 85724
About this study
Official title: Time-efficient Inspiratory Muscle Strength Training for Improving Blood Pressure and Vascular Function in Older Adults With Sleep Disordered Breathing
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.
Read the detailed description
Exercise has well-documented benefits for systolic blood pressure (SBP) and cardiovascular health. Whereas current guidelines advocate ~150 min moderate intensity exercise/week, our preliminary data show ~5 min/day of inspiratory muscle strength training (IMST) for 6 weeks lowers casual (resting) SBP by ~12 mmHg.
This simple approach to lowering BP could be applied to almost any population however we are studying IMST in older adults with obstructive sleep apnea (OSA). OSA is an ideal population to target because OSA prevalence is growing and because snoring and apneas result in chronic intermittent hypoxemia that drives sympathetic nervous system (SNS) hyperactivity, endothelial dysfunction and hypertension. These substantive risks for cardiovascular disease are compounded by poor adherence to the mainstay treatment continuous positive airway pressure (<50%), obesity, fatigue and a robust intolerance for exercise.
Our findings in healthy young adults (n=50) show IMST-related reductions in BP are mediated by decreases in systemic vascular resistance, suggesting changes in vascular tone and function. Consistent with this hypothesis, our results from a pilot clinical trial in adults with OSA (n=24) show IMST-related reductions in plasma norepinephrine levels (PNE) and muscle sympathetic nerve activity (MSNA), both markers of SNS activity. Our preliminary mechanistic assessments indicate IMST may lower circulating concentrations of other vasoconstrictor factors and increase nitric oxide (NO)-mediated endothelium-dependent dilation. And, findings in a novel endothelial cell culture model, point to increases in NO and declines in reactive oxygen species (ROS) and oxidative stress. However, it is unknown if: 1) IMST lowers casual and 24-h (ambulatory) SBP in older adults with OSA; 2) the reductions in SBP are long-lasting; 3) arterial stiffness, NO-mediated endothelial dilation and/or oxidative stress are improved; and 4) if adherence in this population is high long term.
In this randomized, double-blind clinical trial we will establish the efficacy of high-intensity IMST (75% maximum inspiratory pressure, [PImax]) 5 days/week for 24 weeks vs. low-intensity IMST (15%PImax) (n=61/group) for lowering SBP in adults (>50 years) with above normal BP and OSA. We hypothesize that IMST will lower SBP via reductions in SNS activity and circulating vasoconstrictor factors, improvements in vascular function, and reductions in oxidative stress/inflammation and that reductions in SBP will be sustained 4 and 12 weeks post-intervention.
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Being tested
- Inspiratory Muscle Strength Training
- Keywords
- Inspiratory Muscle Strength Training, Blood Pressure, Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Strength TrainingBehavioural
30 breaths/ day, 5 days/week for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Training Group A | Experimental | Participants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device. Receives: 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. Receives: Behavioral: Inspiratory Muscle Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
The secondary endpoint is 24-hour ambulatory systolic blood pressure measured by both relative and absolute changes from baseline. We will obtain continuous measures of systolic and diastolic blood pressure over a 24-h period with an FDA approved and European Society of Hypertension validated Non-Invasive Ambulatory Blood Pressure monitor. Blood pressure data will be broken into daytime (16 hour) and nighttime (8 hour) segments according to participants' individual sleep-wake cycles. Mean systolic and diastolic blood pressures (mmHg) will be calculated for the daytime and nighttime periods to evaluate circadian systolic and diastolic blood pressure profiles.
Measured: 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
The secondary endpoint is Plasma Norepinephrine (PNE), a marker of sympathetic activity, measured by both relative and absolute changes from baseline. PNE will be determined from venous (antecubital area) blood samples and quantified via high performance liquid chromatography (HPLC). PNE will be measured following a fasting blood draw collected between the hours of 7:00 and 10:00 am, preceded by 30 minutes supine rest in a quiet, temperature-controlled room.
Measured: Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), University of Colorado, Boulder
- Responsible party
- Principal investigator, Elizabeth Fiona Bailey, PhD, University of Arizona
- Investigators
- Elizabeth F Bailey, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932447
- Sponsor's protocol ID
- 1200000220
- Other IDs
- 1R01AG065346-01A1
- Status last verified
- Oct 2025
- First submitted
- 27 Apr 2021
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 33600284Ramos-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.
PubMed 32730174DeLucia 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.
PubMed 29178489Vranish 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.
PubMed 27091540Vranish 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.
PubMed 26112283Tavoian 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.
PubMed 34901220
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-efficient Inspiratory Muscle Strength Training for Improving Blood Pressure and Vascular Function in Older Adults With Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT04932447
- Acronym / sponsor ID
- 1200000220
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Keywords
- Inspiratory Muscle Strength Training, Blood Pressure, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), University of Colorado, Boulder
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exercise has well-documented benefits for systolic blood pressure (SBP) and cardiovascular health. Whereas current guidelines advocate ~150 min moderate intensity exercise/week, our preliminary data show ~5 min/day of inspiratory muscle strength training (IMST) for 6 weeks lowers casual (resting) SBP by ~12 mmHg.
This simple approach to lowering BP could be applied to almost any population however we are studying IMST in older adults with obstructive sleep apnea (OSA). OSA is an ideal population to target because OSA prevalence is growing and because snoring and apneas result in chronic intermittent hypoxemia that drives sympathetic nervous system (SNS) hyperactivity, endothelial dysfunction and hypertension. These substantive risks for cardiovascular disease are compounded by poor adherence to the mainstay treatment continuous positive airway pressure (<50%), obesity, fatigue and a robust intolerance for exercise.
Our findings in healthy young adults (n=50) show IMST-related reductions in BP are mediated by decreases in systemic vascular resistance, suggesting changes in vascular tone and function. Consistent with this hypothesis, our results from a pilot clinical trial in adults with OSA (n=24) show IMST-related reductions in plasma norepinephrine levels (PNE) and muscle sympathetic nerve activity (MSNA), both markers of SNS activity. Our preliminary mechanistic assessments indicate IMST may lower circulating concentrations of other vasoconstrictor factors and increase nitric oxide (NO)-mediated endothelium-dependent dilation. And, findings in a novel endothelial cell culture model, point to increases in NO and declines in reactive oxygen species (ROS) and oxidative stress. However, it is unknown if: 1) IMST lowers casual and 24-h (ambulatory) SBP in older adults with OSA; 2) the reductions in SBP are long-lasting; 3) arterial stiffness, NO-mediated endothelial dilation and/or oxidative stress are improved; and 4) if adherence in this population is high long term.
In this randomized, double-blind clinical trial we will establish the efficacy of high-intensity IMST (75% maximum inspiratory pressure, [PImax]) 5 days/week for 24 weeks vs. low-intensity IMST (15%PImax) (n=61/group) for lowering SBP in adults (>50 years) with above normal BP and OSA. We hypothesize that IMST will lower SBP via reductions in SNS activity and circulating vasoconstrictor factors, improvements in vascular function, and reductions in oxidative stress/inflammation and that reductions in SBP will be sustained 4 and 12 weeks post-intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Training Group A | Experimental | Behavioral: Inspiratory Muscle Strength TrainingParticipants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device. |
| Training Group B | Sham comparator | Behavioral: Inspiratory Muscle Strength TrainingParticipants will perform their respiratory training (low-intensity, low-volume IMST) on a hand-held respiratory training device. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- Age <50
- AHI <15
- Individuals with central or mixed sleep disordered breathing
- Severe hypoxemia (<80% for >10% of recording time) during sleep
- ESS >15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Strength Training30 breaths/ day, 5 days/week for 24 weeks. | Behavioural | Training Group A, Training Group B |
Primary outcome
Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Time frame: Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST
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.
2 secondary outcomes
Change from baseline 24-hour Ambulatory Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks
Time frame: 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
Time frame: Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Background: PubMed 33600284DeLucia 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.
- Background: PubMed 32730174Ramos-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.
- Background: PubMed 29178489DeLucia 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.
- Background: PubMed 27091540Vranish 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.
- Background: PubMed 26112283Vranish 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.
- Derived from this study: PubMed 34901220Tavoian 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.
- Pre-screening questionnaire for interested participantsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth F Bailey, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Strength Training in people with Obstructive Sleep Apnea and Hypertension, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks (time frame: Measured at Baseline, Week 24, Week 28, and Week 36 to establish the intermediate and long-lasting effects of IMST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932447, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.