NCT07349706Recruiting
IMST for Dementia Risk Reduction
Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 17 Nov 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Florida State University
- Diseases
- Depression
- NCT number
- NCT07349706
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 17 Nov 2025 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent respiratory therapy or major medication changes
- Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Florida State University Coordinator of this site? Confirm its status | Tallahassee | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.