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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 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.

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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

Conditions Studied

Mild Cognitive Impairment Healthy Aging

Interventions

  • BEHAVIORAL RFB
  • BEHAVIORAL VSOP
  • BEHAVIORAL IR

Study Locations (1)

New York

  • Feng Lin - Rochester

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2020-08-18
Est. Completion 2026-02-28
Phase Phase 2

Sponsor

University of Rochester

636 total trials

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What the Registry Record Tells You About NCT04522791

The ClinicalTrials.gov registry entry for NCT04522791 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.