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

Inclusion Criteria6

Ages 60-80
Converted telephone MoCA total score≥18
Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \[SBP \>130 mmHg or on medication\], sedentary lifestyle \[\<150 min/week\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \[\>5\]
Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)
Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)
Optional inclusion of inspiratory muscle weakness (MIP \<80 cmH₂O for men, \<70 cmH₂O for women) will also be assessed.

Exclusion Criteria9

tMoCA \<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)
Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \> 20)
Unstable cardiovascular or pulmonary disease
Recent respiratory therapy or major medication changes
Self-reported severe untreated or unstable obstructive sleep apnea (OSA)
Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training
Lung and eardrum injuries
Non-English speaking
Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.

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.