NCT03494361

Brief Summary

The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity. Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process. First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role. Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

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

Study Start

First participant enrolled

July 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

April 2, 2018

Last Update Submit

July 22, 2020

Conditions

Keywords

deglutition disorderselectromyography

Outcome Measures

Primary Outcomes (1)

  • Latency

    the latency of muscular activation

    once at study, when patient enrolled

Secondary Outcomes (1)

  • duration

    once at study, when patient enrolled

Study Arms (2)

Young normal group

normal participants below 60 years

Old normal group

normal participants above 60 years

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants

You may qualify if:

  • Age \> 60, without dysphagia, comorbidity
  • Age \< 60, without dysphagia, comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 11, 2018

Study Start

July 4, 2016

Primary Completion

November 21, 2017

Study Completion

November 21, 2017

Last Updated

July 23, 2020

Record last verified: 2020-07