Home-based inspiratory muscle training to lower dementia risk in older adults
Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults
This study will test whether an 8-week, daily home inspiratory breathing program can lower blood pressure and improve thinking, mood, and sleep in adults aged 60–80 who have risk factors for dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07349706 on ClinicalTrials.gov |
What this trial studies
This is a 2-arm, randomized pilot trial of 30 adults aged 60–80 with cardiovascular risk factors for dementia. Participants are randomized to daily high-resistance IMST (about 75% maximal inspiratory pressure) or a low-resistance sham IMST (about 15% MIP) performed at home for 8 weeks. Outcomes include changes in systolic blood pressure and vascular health, executive cognitive function, mood, sleep (self-report and actigraphy), inflammation, and physical function, with assessments at baseline, weekly during the intervention, and at the 8-week conclusion. Investigators will also measure adherence and acceptability, targeting at least 80% adherence to prescribed sessions.
Who should consider this trial
Good fit: Adults aged 60–80 who have one or more dementia risk factors (for example, hypertension, mild cognitive concerns or MCI, sedentary lifestyle, family history or APOE ε4) and can perform brief daily inspiratory muscle training are ideal candidates.
Not a fit: People with significant cognitive impairment below the inclusion threshold, major psychiatric disorders, severe respiratory or neurological disease, or who cannot perform the breathing device protocol are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, IMST could provide a short, low-cost, home-based way to lower systolic blood pressure and potentially improve cognition, mood, and sleep in older adults at risk for dementia.
How similar studies have performed: Small prior studies have shown IMST can reduce systolic blood pressure and improve respiratory muscle strength, but its effects on cognition, mood, and sleep are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tallahassee, Florida
- Florida State University — Tallahassee, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.