NCT05444114

Brief Summary

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to provide verbal descriptions of photographs. Participants will perform a brief mental exercise, then see three photographs with instructions to describe each thoroughly. Participants will also complete several other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to speech production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 18, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 22, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

June 18, 2022

Results QC Date

May 30, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

speech productioncognitive aging

Outcome Measures

Primary Outcomes (5)

  • Speech Rate

    Average number of words per second spoken

    During the 40 to 60 minute experimental session

  • Speech Fillers Mid-Phrase

    Average number of mid-phrase speech fillers as a percentage of words spoken

    During the 40 to 60 minute experimental session

  • Speech Fillers Other

    Average number of speech fillers not in the middle of a phrase as a percentage of words spoken

    During the 40 to 60 minute experimental session

  • Repairs Plus False Starts

    Average number of repairs plus false starts as a percentage of words spoken. These two measures reflect the same underlying process so are summed together; indeed, one or the other term is sometimes used to indicate both measures.

    During the 40 to 60 minute experimental session

  • Repetitions

    Average number of repetitions as a percentage of words spoken

    During the 40 to 60 minute experimental session

Study Arms (2)

Mindful Breathing

EXPERIMENTAL

Participants follow instructions regarding a mindful breathing exercise on a 10-min audio clip

Behavioral: Mental Exercise

Control

ACTIVE COMPARATOR

Participants follow instructions and listen to a 10-min audio clip of a story

Behavioral: Mental Exercise

Interventions

Mental ExerciseBEHAVIORAL

Participants perform a 10 minute mental exercise that is either mindful breathing or listening to a story

ControlMindful Breathing

Eligibility Criteria

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

You may qualify if:

  • fluent speakers of English
  • ages 18-30 or ages 65-80

You may not qualify if:

  • non-fluent speakers of English
  • people who are not ages 18-30 or ages 65-80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCCS

Colorado Springs, Colorado, 80918, United States

Location

Results Point of Contact

Title
Lori James
Organization
University of Colorado Colorado Springs

Study Officials

  • Lori James, PhD

    University of Colorado, Colorado Springs

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in each condition do not know what other participants are doing, nor that there is another condition.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two conditions before performing a picture description task from which we measure speech fluency in several ways
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2022

First Posted

July 5, 2022

Study Start

August 22, 2022

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

August 22, 2024

Results First Posted

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

De-identified participant data may be posted on a website for open access to other researchers, if the publication outlet requires it., but is not currently planned.

Locations