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Trial record 94 of 6995 for:    Oral Cancer | ( Map: United States )

Effect of Different Viscous Foods and Liquids on Swallowing Sounds

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ClinicalTrials.gov Identifier: NCT03024333
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chun Feng, University of Nebraska

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.

Condition or disease
Deglutition Disorder

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Effect of Different Viscous Foods and Liquids on Swallowing Sounds
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Duration(s) of swallowing sounds among healthy subjects [ Time Frame: 2 hours ]
    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. Amplitude(W/m2) of swallowing sounds among healthy subjects [ Time Frame: 2 hours ]
    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.

  3. Mean frequency(Hz) of swallowing sounds among healthy subjects [ Time Frame: 2 hours ]
    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.

  4. Power spectrum(W/Hz) of swallowing sounds among healthy subjects [ Time Frame: 2 hours ]
    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.


Secondary Outcome Measures :
  1. Sound duration(s) of coughing sound and throat clearing among healthy subjects [ Time Frame: 2 hours ]
    Investigators will distinguish the differences in sound duration(s) between throat clearing and coughing in healthy subjects.

  2. Mean frequency(Hz) of coughing sound and throat clearing among healthy subjects [ Time Frame: 2 hours ]
    Investigators will distinguish the differences in mean frequency(Hz) between throat clearing and coughing in healthy subjects.

  3. Power spectrum(W/Hz) of coughing sound and throat clearing among healthy subjects [ Time Frame: 2 hours ]
    Investigators will distinguish the differences in power spectrumin(W/Hz) between throat clearing and coughing in healthy subjects.



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  1. Have poor dentition and neurological conditions.
  2. 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.
  3. Have esophageal diseases such as esophageal cancers, esophageal foreign body feelings, esophagitis, etc. Neuromuscular disorders such as esophageal spasm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024333


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Study Chair: Chun Ka Siu, PhD University of Nebraska

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Responsible Party: Chun Feng, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT03024333     History of Changes
Other Study ID Numbers: 782-16-FB
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Keywords provided by Chun Feng, University of Nebraska:
Dysphagia
Swallowing Sound
Acoustic Analysis

Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases