Breathing Training for Sleep Apnea

Overseen By Adrielle Barcibal, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Diabetes, Chronic kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 33

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how breathing exercises can improve blood pressure and heart health in individuals with moderate to severe obstructive sleep apnea. Participants will perform either high-intensity or low-intensity breathing exercises using a handheld device. This method, known as Inspiratory Muscle Strength Training (IMST), suits those 50 and older who struggle with standard sleep apnea treatments like CPAP or other devices. As an unphased trial, this study provides a unique opportunity for participants to explore alternative treatments that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires that you maintain your current medication regimen throughout the study, so you won't need to stop taking your current medications.

What prior data suggests that this respiratory training is safe for adults with sleep apnea?

A previous study showed that breathing exercises to strengthen inhalation muscles yielded promising results for people with obstructive sleep apnea. Participants who practiced these exercises for just 5 minutes a day experienced better sleep and lower blood pressure. Another study found that an 8-week program of these exercises improved both breathing muscle strength and heart health. Importantly, these studies reported no major adverse side effects, suggesting that the exercises are generally safe and well-tolerated for adults with sleep apnea. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Inspiratory Muscle Strength Training (IMST) for sleep apnea because it offers a different approach compared to traditional treatments like CPAP machines and oral appliances. IMST is unique because it focuses on strengthening the respiratory muscles using a hand-held device, potentially making it a more accessible and convenient option. This method could improve breathing during sleep without the need for cumbersome equipment or surgical intervention, offering hope for a more user-friendly solution to managing sleep apnea.

What evidence suggests that Inspiratory Muscle Strength Training is effective for sleep apnea?

Research has shown that inspiratory muscle strength training (IMST) can improve well-being in people with obstructive sleep apnea (OSA). In this trial, participants will be divided into two groups: Training Group A will perform high-intensity, low-volume IMST, while Training Group B will perform low-intensity, low-volume IMST as a sham comparator. Studies have found that IMST strengthens breathing muscles and enhances sleep quality, reducing daytime sleepiness. Evidence also indicates that this training can help individuals fall asleep faster. Importantly, IMST has been shown to lower blood pressure, benefiting heart health. Overall, these findings suggest that IMST could improve both breathing and heart health in those with OSA. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth F Bailey, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

Adults aged 50+ with moderate to severe obstructive sleep apnea, who don't use CPAP or are adherent to alternative treatments like mandibular devices. Participants should have stable weight and medication regimens, no recent drug abuse, and be free from unstable diseases. They must have a BMI ≤40 kg/m^2, blood pressure ≥120/≤160 mmHg, cholesterol <240 mg/dL, fasting glucose <300 mg/dL.

Inclusion Criteria

I haven't changed my blood pressure or any other medications in the last 3 months and am willing to keep them the same during the study.

I understand and can follow the study's procedures.

I am 50 years old or older.

Exclusion Criteria

Your score on the ESS (Epworth Sleepiness Scale) is higher than 15.

I have a long-term health condition like diabetes or heart failure that is not well-managed.

You have an Apnea-Hypopnea Index (AHI) of less than 15.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform inspiratory muscle strength training (IMST) for 24 weeks, with high-intensity and low-intensity groups

24 weeks

5 sessions per week

Follow-up

Participants are monitored for the intermediate and long-lasting effects of IMST on blood pressure and cardiovascular health

12 weeks

Assessments at Week 28 and Week 36

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Strength Training

Trial Overview The trial is testing Inspiratory Muscle Strength Training (IMST) to see if it can improve blood pressure and cardiovascular health in older adults with obstructive sleep apnea. Participants will be randomly assigned to either undergo IMST or not as part of the study.

How Is the Trial Designed?

Group I: Training Group A Experimental Treatment 1 Intervention

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

Group II: Training Group B Placebo Group 1 Intervention

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

Inspiratory Muscle Strength Training is already approved in United States, European Union for the following indications:

Approved in United States as Inspiratory Muscle Strength Training for:

• Obstructive Sleep Apnea
• Cardiovascular Health Improvement
• Blood Pressure Management

Approved in European Union as Inspiratory Muscle Strength Training for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Cardiovascular Health Improvement
• Respiratory Muscle Weakness

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Published Research Related to This Trial

Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

Inspiratory muscle training (IMT) significantly improves sleepiness and sleep quality in patients with obstructive sleep apnoea (OSA), as evidenced by reductions in the Epworth sleepiness scale and Pittsburgh sleep quality index scores based on a systematic review of 210 patients across eight studies.

IMT also enhances inspiratory strength, indicated by an increase in maximum inspiratory pressure, although it did not affect the apnoea/hypopnea index or physical capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Training in Patients with Obstructive Sleep Apnoea: A Systematic Review and Meta-Analysis. Torres-Castro, R., Solis-Navarro, L., Puppo, H., et al.[2023]

A study involving 40 critically ill patients showed that using an electronic device for inspiratory muscle training (IMT) was feasible, with 81% of planned sessions completed, indicating good adherence to the intervention.

The electronic IMT was found to be safe, with no major adverse events and only 10% minor adverse events that were transient and without clinical consequences, while over 85% of participants reported it as helpful for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. Nickels, M., Erwin, K., McMurray, G., et al.[2023]

Inspiratory muscle training (IMT) over 12 weeks significantly improved sleep quality in patients with obstructive sleep apnea (OSA), as measured by the Pittsburgh Sleep Quality Index, compared to a placebo group.

However, IMT did not lead to significant improvements in lung function, respiratory muscle strength, or exercise capacity, indicating that while it may enhance sleep quality, it does not affect overall physical performance in OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial. Souza, AKF., Dornelas de Andrade, A., de Medeiros, AIC., et al.[2019]

Inspiratory muscle training (IMT) has shown beneficial effects on respiratory health in both healthy individuals and those with diseases, highlighting its potential as a therapeutic intervention.

The article aims to compare different IMT methods and their outcomes, specifically focusing on the Test of Incremental Respiratory Endurance (TIRE), which could help identify the most effective training approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). Cahalin, LP., Arena, R.[2022]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and efficiency in 22 professional male soccer players, leading to enhanced performance in repeated sprint ability (RSA) and reduced sprint times after a 2-week intervention.

The study found significant increases in maximal inspiratory pressure (MIP) and peak inspiratory flow (PIF), indicating that IMT not only boosts muscle strength but also enhances overall exercise tolerance in athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. Cavalcante Silva, RL., Hall, E., Maior, AS.[2020]

Inspiratory muscle training (IMT) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

Inspiratory muscle training (IMT) significantly improves balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., et al.[2023]

Inspiratory muscle training (IMT) has been shown to significantly improve inspiratory muscle function, dyspnea, and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD), based on a review of 15 randomized trials.

High-intensity IMT specifically enhances inspiratory muscle strength, but its effects on other clinical outcomes, such as exercise tolerance, remain unclear, indicating a need for further research to clarify these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. Shoemaker, MJ., Donker, S., Lapoe, A.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8599350/

Inspiratory Muscle Training for Obstructive Sleep Apnea Regardless of the mechanism, the evidence suggests that IMT has the potential to improve both breathing and cardiovascular symptoms in OSA.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9670769/

Effects of inspiratory muscle training in patients with ... IMT may be considered as an effective treatment strategy in mild to severe OSA resulting in improved inspiratory muscle strength, sleep quality, daytime ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07149233

Effectiveness of Inspiratory Muscle Training on Sleep in ... Expected Results: It is expected that 4 weeks of IMT in patients with OSA will reduce excessive daytime sleepiness, sleep latency, number of ...

4. mdpi.com mdpi.com/2624-5175/4/2/20

Respiratory Muscle Training in Patients with Obstructive ... Conclusion: IMT improves sleepiness, sleep quality and inspiratory strength in patients with OSA.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4863204/

Inspiratory Muscle Training Improves Sleep and Mitigates ... 5 minutes of inspiratory muscle training a day improves sleep and reduces blood pressure and plasma catecholamines in adults with obstructive sleep apnea.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12387955/

Inspiratory Muscle Training Improves Respiratory ... Conclusion: An 8-week 80%MIP IMT intervention significantly improves respiratory muscle strength and cardiovascular autonomic regulation in ...

7. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1549652/full

Effectiveness of inspiratory muscle training in patients with ... Conclusion: IMT improved several clinically relevant outcomes, including MIP, exercise capacity, and dyspnoea in different CRDs. However, the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02259660

Airway Muscle Training for Obstructive Sleep Apnea The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study ...