IMST for Dementia Risk Reduction

NCT07349706 | Recruiting FDA Device

• 1 other identifier: STUDY00006529
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in systolic BP

  Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.

  Baseline, 8-weeks

• Change in executive cognitive functioning

  Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.

  Baseline, 8 weeks

Secondary Outcomes (7)

• Change from Baseline in Mood Symptoms (Depression) at 8 Weeks

  Baseline, 8 weeks

• Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks

  Baseline, 8 weeks

• Change from Baseline in Sleep Quality at 8 Weeks

  Baseline, 8 weeks

• Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks

  Baseline, 8 weeks

• Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks

  Baseline, 8 weeks

Study Arms (2)

High-Resistance

EXPERIMENTAL

Participants assigned to the high resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 75% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, consisting of 30 breaths per day, completed in a minimum of 5 minutes.

Device: Inspiratory Muscle Strength Training High-Resistance

Control Group - Low-Resistance

SHAM COMPARATOR

Participants assigned to the low-resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 15% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, completing 30 inspiratory breaths per day, with each session lasting a minimum of 5 minutes.

Device: Inspiratory Muscle Strength Training Low-Resistance

Interventions

Inspiratory Muscle Strength Training High-Resistance DEVICE

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.

High-Resistance

Inspiratory Muscle Strength Training Low-Resistance DEVICE

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.

Control Group - Low-Resistance

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32301, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)