Home-based inspiratory muscle training to lower dementia risk in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Florida State University
  Tallahassee, Florida, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Think Tank nutritional drink to help thinking after stress in middle-aged women.

  This trial will test whether taking the 'Think Tank' nutritional drink helps thinking and mood after a physical and psychological stressor in healthy women aged 40–60 who drink caffeine daily.

  Recruiting Leeds Beckett University · Leeds, West Yorkshire · NCT07319117

• Pre-visit Companion Brief: a primary care AI-assisted check for depression and anxiety

  This pilot tests an AI-powered pre-visit assessment that creates a concise Companion Brief for clinicians to help identify depression and anxiety during routine primary care.

  Recruiting Singula Health, Inc. · Brentwood, New York and 1 other locations · NCT07834684

• Mobile CBT for mood after a stroke

  A mobile CBT app called Maya is tested to see if it helps adults recently recovering from stroke manage depression and anxiety during rehab.

  Recruiting Weill Medical College of Cornell University · New York, New York · NCT07639606

• Group-based ACT for psychological distress in young people

  Researchers are testing whether group-based ACT helps 16-25 year olds with depression or anxiety more than the usual individual therapy.

  Recruiting at 2 sites Sorlandet Hospital HF · Arendal, Agder and 1 other locations · NCT07617467

• Behavioral health collaborative care for family members of ICU survivors in the Post-ICU clinic pilot

  This pilot tests a telehealth-based behavioral health program using the NeuroFlow app for family members of ICU survivors to try to reduce anxiety, depression, and PTSD symptoms.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07390786

• No Time to Wait — Single-Session Growth-Mindset Program for Teens

  This project will try a single-session online growth-mindset program to help Hong Kong adolescents aged 12–17 who have elevated depression or anxiety symptoms.

  Recruiting United Christian Hospital · Hong Kong · NCT07383467

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.