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NCT04522791 · ClinicalTrials.gov registry record · Phase 2
Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
A Phase 2 study of Mild Cognitive Impairment and Healthy Aging, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT04522791: Recruiting Phase 2 study of Mild Cognitive Impairment and Healthy Aging, sponsored by University of Rochester.
NCT04522791 is a Phase 2 study of Mild Cognitive Impairment and Healthy Aging that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 114 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04522791, a Phase 2 study of Mild Cognitive Impairment and Healthy Aging, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study Summary
A recently completed study suggested that processing speed and attention (PS/A) oriented cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in cognitive control or episodic memory, and long-term effects were overall modest. The proposed R01 renewal proposes to identify additional attributes to further enhance transferred and long-term effects of PS/A training in older adults with amnestic mild cognitive impairment (MCI) by addressing adaptation capacity that underpins adaptive learning and neuroplasticity. The goal of the stage II double-blinded randomized trial is to test whether adding resonance frequency breathing (RFB) training to VSOP will strengthen multiple contributors to adaptation capacity, particularly the central and peripheral pathways of autonomic nervous system (ANS) flexibility, which will strengthen VSOP training effect on cognitive and brain function and slow the progress of dementia in MCI. The central hypothesis is that strengthening adaptation capacity, via improving autonomic nervous system (ANS) flexibility, will enhance neuroplasticity and slow progress of dementia in MCI, since adaptation capacity is critical for neuroplasticity of VSOP, but compromised in neurodegenerative process. Older adults with MCI (n = 114) will be randomly assigned to an 8-week combined intervention (RFB+VSOP), VSOP with guided imagery relaxation (IR) control, and a waitlist IR control, with periodical booster training sessions at follow-ups. Mechanistic and distal outcomes include ANS flexibility and multiple markers of dementia progress. Data will be collected across a 14-month period. The two primary aims are to examine long-term effects of the combined intervention on ANS flexibility (Aim 1), as well as the cognitive, behavioral, and functional capacity (Aim 2). The exploratory aim will be to determine the preliminary long-term effect of the combined intervention on neurodegeneration. This can be a reasonable renewal plan from th
Primary Outcome
A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.
Conditions Studied
Interventions
- BEHAVIORAL RFB
- BEHAVIORAL VSOP
- BEHAVIORAL IR
Study Locations (1)
New York
- Feng Lin - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
What NCT04522791 shows while recruiting
NCT04522791 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 3 interventions - of which RFB is the first listed.
NCT04522791 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04522791 about?
NCT04522791 is a clinical study titled "Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)". A recently completed study suggested that processing speed and attention (PS/A) oriented cognitive training (VSOP) produced robust effect on PS/A and working memory, but not in cognitive control or episodic memory, and long-term effects were overall modest. The proposed R01 renewal proposes to ident...
What is the current status of trial NCT04522791?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2020-08-18. Estimated completion is 2026-02-28.
What conditions does trial NCT04522791 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Healthy Aging.
What interventions are being tested in trial NCT04522791?
The interventions under investigation include: RFB (BEHAVIORAL), VSOP (BEHAVIORAL), IR (BEHAVIORAL).
Who is sponsoring clinical trial NCT04522791?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04522791 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Cognitive Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04522791's enrollment target sits among peer trials
114 86th of 205 higher than 120 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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