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

122 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if a breathing exercise called Inspiratory Muscle Strength Training (IMST) can lower blood pressure in adults over 50 with sleep apnea. The exercise strengthens breathing muscles, which may help relax blood vessels and reduce heart stress. Researchers hope this will be an effective treatment for those who don't respond well to other methods. Inspiratory Muscle Strength Training (IMST) has been shown to lower blood pressure and improve cardiovascular health in various populations, including those with obstructive sleep apnea.

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 data supports the effectiveness of the treatment Inspiratory Muscle Strength Training (IMST) for sleep apnea?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and endurance, which may help people with sleep apnea. A study specifically found that IMT improved sleep and exercise capacity in those with obstructive sleep apnea. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been used safely in both healthy people and those with various health conditions, including older adults and patients with chronic obstructive pulmonary disease (COPD). It is generally considered safe and has been shown to improve breathing strength and other health aspects. ^{2 3 6 7 8}

How is the treatment Inspiratory Muscle Strength Training (IMST) different from other treatments for sleep apnea?

Inspiratory Muscle Strength Training (IMST) is unique because it focuses on strengthening the muscles used for breathing, which can improve sleep quality and exercise capacity in people with sleep apnea. Unlike other treatments like positive pressure devices or surgery, IMST is a non-invasive exercise-based approach that targets the respiratory muscles directly. ^{4 5 6 9 10}

Research Team

Elizabeth F Bailey, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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) 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]

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) 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 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) 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) 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

4. Germany 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. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]

6. Australia 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Training in Patients with Obstructive Sleep Apnoea: A Systematic Review and Meta-Analysis. [2023]