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IMST for Dementia Risk Reduction

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…

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ClinicalTrials.gov IDNCT07349706

PhaseNA

Enrollment30

SponsorFlorida State University

Age60 Years and older

SexALL

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Conditions studied

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

About this study

Interventions

Device: Inspiratory 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.
Device: Inspiratory 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.

Primary outcomes

Change in systolic BP (Baseline, 8-weeks)
Change in executive cognitive functioning (Baseline, 8 weeks)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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.

Study locations

Florida State University, Tallahassee, Florida 32301 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.