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Breathing Training for Sleep Apnea

LE
AH
DT
DT
AB
Overseen ByAdrielle Barcibal, BS
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.12345

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.23678

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.456910

Research Team

EF

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.
See 14 more

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.
See 9 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Training Group AExperimental Treatment1 Intervention
Participants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device.
Group II: Training Group BPlacebo Group1 Intervention
Participants will perform their respiratory training (low-intensity, low-volume IMST) on a hand-held respiratory training device.

Find a Clinic Near You

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.
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.
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.
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]

References

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. [2022]
Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]
Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]
Effectiveness of inspiratory muscle training on sleep and functional capacity to exercise in obstructive sleep apnea: a randomized controlled trial. [2019]
[Inspiratory muscle training during pulmonary rehabilitation]. [2021]
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]
The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]
Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). [2022]
Inspiratory muscle training improves performance of a repeated sprints ability test in professional soccer players. [2020]
Respiratory Muscle Training in Patients with Obstructive Sleep Apnoea: A Systematic Review and Meta-Analysis. [2023]