IMST for Dementia Risk Reduction (NCT07349706) | Clinical Trial Compass
RecruitingNot Applicable
IMST for Dementia Risk Reduction
United States30 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range60 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cmHâ‚‚O for men, \<70 cmHâ‚‚O 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 anal…