What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and pharmacologic therapy. CPAP can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Oral appliances may lead to jaw discomfort, dry mouth, and excessive salivation. Pharmacologic treatments, like the carbonic anhydrase inhibitor sulthiame, can cause intermittent paraesthesias and other side effects leading to withdrawal in some patients. Respiratory strength training, which aims to improve breathing efficiency and reduce cardiovascular strain, is being studied for its potential benefits, but specific side effects are not well-documented yet.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Obstructive Sleep Apnea (OSA) that are directly related to respiratory strength training in the provided context. However, common treatments for OSA include positive airway pressure (PAP) therapy, oral appliances, and upper airway surgical interventions. Emerging therapies such as nasal expiratory positive airway pressure, oral negative pressure, and upper airway muscle stimulation are also being explored. Pharmacotherapy has not shown significant effectiveness but may be used adjunctively for specific cases.

What other types of research exist?

Promising, novel alternatives to respiratory strength training for obstructive sleep apnea patients include electrical stimulation of the upper airway dilator muscles, hypoglossal nerve stimulation, oral appliance therapy, and diaphragm pacing. These treatments are being investigated for their potential to improve breathing efficiency and reduce cardiovascular strain in patients who do not respond well to standard therapies.

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Behavioral Intervention

Breathing Training for Sleep Apnea

N/A

Recruiting

Led By Elizabeth F Bailey, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand study procedures and to comply with them for the entire length of the study

Age 50 and older

Must not have

Chronic overt and poorly controlled medical condition (e.g., diabetes, chronic kidney disease, cancer, congestive heart failure)

Age <50

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of IMST aren't detailed here, potential risks may include discomfort during training exercises or fatigue due to increased respiratory effort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and can follow the study's procedures.

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I am 50 years old or older.

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My weight has been stable for the last 3 months and I can keep it stable during the study.

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I cannot or will not use CPAP for my condition.

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I use my CPAP machine regularly, at least 4 hours a night.

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I use my CPAP machine regularly, at least 4 hours a night for most nights.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 50 years old.

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I experience a specific pattern of breathing that speeds up and slows down.

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I have a sleep disorder that affects my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Secondary study objectives

Change from baseline 24-hour Ambulatory Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Change from baseline Plasma Norepinephrine at 24 weeks, 28 weeks, and 36 weeks

Other study objectives

Change from Baseline 24-hour Ambulatory Diastolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Diastolic blood pressure

Change from Baseline Grip Strength at 24 weeks, 28 weeks, and 36 weeks

+10 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inspiratory Muscle Strength Training

2013

N/A

~40

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, which keeps the airway open by providing a constant stream of air, and surgical interventions that remove or reposition tissues obstructing the airway. Respiratory strength training, such as inspiratory muscle training (IMT) and oropharyngeal exercises (OE), focuses on strengthening the muscles involved in breathing and maintaining airway patency. These exercises improve respiratory muscle strength, enhance breathing efficiency, and reduce cardiovascular strain, which is crucial for OSA patients as it can lead to better sleep quality, reduced daytime sleepiness, and improved overall cardiovascular health.

The effect of oropharyngeal exercise in patients with moderate and severe obstructive sleep apnea using CPAP: a randomized controlled study.The effectiveness of oropharyngeal exercises compared to inspiratory muscle training in obstructive sleep apnea: A randomized controlled trial.Oropharyngeal Muscle Exercise Therapy Improves Signs and Symptoms of Post-stroke Moderate Obstructive Sleep Apnea Syndrome.