Breathing Training for Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen by Elizabeth F Bailey, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Diabetes, Chronic kidney disease, Cancer, others

No Placebo Group

Approved in 2 Jurisdictions

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}

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.

Trial 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 (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Arizona Respiratory and Neurophysiology Laboratory Tucson, AZ

Who Is Running the Clinical Trial?

University of Arizona Lead Sponsor

National Institute on Aging (NIA) Collaborator

National Institutes of Health (NIH) Collaborator

University of Colorado, Boulder Collaborator

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] The purpose of the present review was to assess the quality of evidence in the literature regarding the specific benefits of inspiratory muscle training (IMT) with an emphasis on training intensity and the relationships between changes in inspiratory muscle function and other clinical outcome measures.

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

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023] Inspiratory muscle training (IMT) aims to improve respiratory muscle strength and endurance. Clinical trials used various training protocols, devices and respiratory measurements to check the effectiveness of this intervention. The current guidelines reported a possible advantage of IMT, particularly in people with respiratory muscle weakness. However, it remains unclear to what extent IMT is clinically beneficial, especially when associated with pulmonary rehabilitation (PR). OBJECTIVES: To assess the effect of inspiratory muscle training (IMT) on chronic obstructive pulmonary disease (COPD), as a stand-alone intervention and when combined with pulmonary rehabilitation (PR).

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] Inspiratory muscle strength training (IMST) has been traditionally recommended for patients with chronic obstructive pulmonary disease (COPD) to improve respiratory strength. Respiratory strength is reduced as age increases. However, few studies have focused on the effects of IMST on older adults without COPD.

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] The aim of this study was to evaluate the effectiveness of inspiratory muscle training (IMT) on sleep and functional capacity to exercise in subjects with obstructive sleep apnea (OSA).

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

[Inspiratory muscle training during pulmonary rehabilitation]. [2021] Inspiratory muscle training (IMT) is part of the management of patients with pulmonary diseases during rehabilitation. Since the last recommendations of the Société de pneumologie de langue française, several studies have focused on the role of inspiratory muscle training during pulmonary rehabilitation.

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] Inspiratory muscle training (IMT) is an intervention that can be used to rehabilitate the respiratory muscle deconditioning experienced by patients with critical illness, requiring prolonged mechanical ventilation. Clinicians are currently using mechanical threshold IMT devices that have limited resistance ranges.

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

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023] Inspiratory muscle training (IMT) has been widely used in both healthy and diseased populations especially in older adults, and its effects have been proven not only on inspiratory muscle strength but also on dyspnea, exercise capacity, quality of life, and other health parameters.

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

Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). [2022] The favorable effects of inspiratory muscle training (IMT) in health and disease are becoming much more apparent. A variety of IMT methods exist, but few studies have compared IMT methods. The purpose of this article is to review the methods and outcomes of the Test of Incremental Respiratory Endurance (TIRE).

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

Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. [2020] Inspiratory muscle training (IMT) is an important method of attenuating both respiratory and peripheral effort perceptions, consequently improving neuromuscular performance and resulting in greater improvements in exercise capacity than exercise training alone.

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

Respiratory Muscle Training in Patients with Obstructive Sleep Apnoea: A Systematic Review and Meta-Analysis. [2023] Background: Effective treatments for obstructive sleep apnoea (OSA) include positive pressure, weight loss, oral appliances, surgery, and exercise. Although the involvement of the respiratory muscles in OSA is evident, the effect of training them to improve clinical outcomes is not clear. We aimed to determine the effects of respiratory muscle training in patients with OSA. Methods: A systematic review was conducted in seven databases. Studies that applied respiratory muscle training in OSA patients were reviewed. Two independent reviewers analysed the studies, extracted the data and assessed the quality of evidence. Results: Of the 405 reports returned by the initial search, eight articles reporting on 210 patients were included in the data synthesis. Seven included inspiratory muscle training (IMT), and one included expiratory muscle training (EMT). Regarding IMT, we found significant improvement in Epworth sleepiness scale in −4.45 points (95%CI −7.64 to −1.27 points, p = 0.006), in Pittsburgh sleep quality index of −2.79 points (95%CI −4.19 to −1.39 points, p