RecruitingNot ApplicableNCT07349706

IMST for Dementia Risk Reduction

Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults

Sponsor

Florida State University

Enrollment

30 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Sleep Quality Cognitive Function Blood Pressure Anxiety Depression - Major Depressive Disorder Physical Function Systolic Blood Pressure

Summary

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a simple, home-based breathing exercise called inspiratory muscle strength training (IMST) — where you breathe in through a resistance device for about 5–10 minutes per day — to see if it can reduce the risk of developing dementia in older adults. IMST has been shown to improve cardiovascular function and brain blood flow. **You may be eligible if...** - You are 60–80 years old - You have at least one risk factor for dementia (e.g., mild memory decline, high blood pressure, sedentary lifestyle, family history of dementia, sleep-disordered breathing, or a high dementia risk score) - You scored 18 or higher on a cognitive screening test - You are able to use the breathing device with minimal or no assistance and commit to doing it daily for 8 weeks **You may NOT be eligible if...** - Your cognitive screening score is below 18 or you have a diagnosed neurodegenerative disease (except mild cognitive impairment) - You have a serious psychiatric condition (e.g., bipolar disorder, severe depression, psychosis) - You have unstable heart or lung disease - You have untreated or severe sleep apnea - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInspiratory Muscle Strength Training High-Resistance

Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 75% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.

DEVICEInspiratory Muscle Strength Training Low-Resistance

Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 15% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.