NCT03024333

Brief Summary

This study is aimed to establish and identify the normal pattern of swallowing sounds and analyze swallowing sounds of different textured foods and viscous liquids in healthy subjects to provide clinical evidence to update dysphagia patients' food.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

January 7, 2017

Last Update Submit

September 13, 2023

Conditions

Keywords

DysphagiaSwallowing SoundAcoustic Analysis

Outcome Measures

Primary Outcomes (4)

  • Duration(s) of swallowing sounds among healthy subjects

    Investigators will record the swallowing sound vibrations at the anterior and posterior neck in health subjects, and analyze the duration(s) of swallowing sounds generated by various viscous foods and liquids through the pharynx.

    2 hours

  • Amplitude(W/m2) of swallowing sounds among healthy subjects

    Investigators will record the swallowing sound vibrations at the anterior and posterior neck in health subjects, and analyze the amplitude(W/m2) of swallowing sounds generated by various viscous foods and liquids through the pharynx.

    2 hours

  • Mean frequency(Hz) of swallowing sounds among healthy subjects

    Investigators will record the swallowing sound vibrations at the anterior and posterior neck in health subjects, and analyze mean frequency(Hz) of swallowing sounds generated by various viscous foods and liquids through the pharynx.

    2 hours

  • Power spectrum(W/Hz) of swallowing sounds among healthy subjects

    Investigators will record the swallowing sound vibrations at the anterior and posterior neck in health subjects, and analyze the power spectrum(W/Hz) of swallowing sounds generated by various viscous foods and liquids through the pharynx.

    2 hours

Secondary Outcomes (3)

  • Sound duration(s) of coughing sound and throat clearing among healthy subjects

    2 hours

  • Mean frequency(Hz) of coughing sound and throat clearing among healthy subjects

    2 hours

  • Power spectrum(W/Hz) of coughing sound and throat clearing among healthy subjects

    2 hours

Study Arms (1)

Healthy subjects

Healthy subjects are: 1. Between 19-60 years old 2. Able to sign the informed consent after the whole study is explained to them 3. Self-reporting no history of swallowing disorders, neurological deficits and/or cancer of the mouth, neck or brain, or head or neck surgery 4. Able to sit upright with or without back support of chair 5. No other diseases affect swallowing function

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The participants are between 19-60 years old and able to sign the informed consent. According to self-reporting no history of swallowing disorders, neurological deficits and/or cancer of the mouth, neck or brain, or head or neck surgery, they will be able to sit upright with or without back support of chair. They have no poor dentition and neurological conditions. They don't have other diseases like cervical spondylosis, having pain when swallowing like tonsil inflammation, peritonsillar abscess, retropharyngeal abscess, pharyngeal tumor, epiglottis abscess and other diseases of the throat. They have no esophageal diseases such as esophageal cancers, esophageal foreign body feelings, esophagitis or neuromuscular disorders such as esophageal spasm.

You may qualify if:

  • Between 19-60 years old
  • Able to sign the informed consent after the whole study is explained to them
  • Self-reporting no history of swallowing disorders, neurological deficits and/or cancer of the mouth, neck or brain, or head or neck surgery
  • Able to sit upright with or without back support of chair
  • No other diseases affect swallowing function

You may not qualify if:

  • Have poor dentition and neurological conditions.
  • Have other diseases like cervical spondylosis, having pain when swallowing like tonsil inflammation, peritonsillar abscess, retropharyngeal abscess, pharyngeal tumor, epiglottis abscess and other diseases of the throat.
  • Have esophageal diseases such as esophageal cancers, esophageal foreign body feelings, esophagitis, etc. Neuromuscular disorders such as esophageal spasm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chun K Siu, PhD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2017

First Posted

January 18, 2017

Study Start

May 8, 2017

Primary Completion

October 12, 2017

Study Completion

September 17, 2018

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Acoustic analysis of swallowing sound data will be available for other researchers when all data are analyzed however voice print of IPD are not to be shared with other researchers.

Locations