NCT06405893

Brief Summary

This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Participants will engage with an exercise about mindful breathing or an auditory presentation and then name pictured objects as quickly as they can. They will also complete some surveys and other measures and wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 4, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

AgingMindfulnessSpeech Production

Outcome Measures

Primary Outcomes (2)

  • Response Accuracy for Naming Pictures (% correct)

    Percent of valid trials on which correct object names were provided will be computed. The measure was designed for use in this study.

    Under 1 hour

  • Response Time for Naming Pictures (onset time in ms)

    Mean response onset time for valid trials on which correct object names were provided will be computed. The measure was designed for use in this study.

    Under 1 hour

Study Arms (2)

Mindful Breathing

EXPERIMENTAL

10 minute mindful breathing exercise

Behavioral: Mindful breathing exercise

Control

SHAM COMPARATOR

10 minute recorded info about mindfulness

Behavioral: Mindful breathing exercise

Interventions

Participants do a 10 minute guided mindful breathing exercise or participants do listen to a 10 minute control recording

ControlMindful Breathing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-35 or 60-80
  • Fluent English speaker

You may not qualify if:

  • Younger than 18 years old
  • Between ages 36-59
  • Older than age 80
  • Not a fluent English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCCS

Colorado Springs, Colorado, 80918, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 9, 2024

Study Start

April 4, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual data as of now. If the study is submitted for publication to a journal that requires it, data will be made available.

Locations