NCT02926014

Brief Summary

The aim of this research was to evaluate the lingual tonsil hypertrophy (LTH) grading of patients with dysphagia using videolaryngoscopy and determine the relation of LTH grades to sociodemographic factors and clinical symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

August 27, 2016

Last Update Submit

October 4, 2016

Conditions

Lingual Tonsil HypertrophyDysphagia

Keywords

DysphagiaLingual Tonsil HypertrophyLingual Tonsil Enlargement

Outcome Measures

Primary Outcomes (1)

  • Lingual tonsil enlargement grade on videolaryngoscopy

    Lingual tonsil enlargement grade was assessed using DelGaudio (2008) and Friedman (2015) grading systems during videolaryngoscopy. According DelGaudio severity of LTH was assessed as: grade 0- lingual tonsils are not enlarged; 1- the lingual tonsils are prominent but not in full contact with the epiglottis or obscuring the valleculae; 2- the lingual tonsils obscure the view of the valleculae and are fully in contact with the epiglottis; 3- the lingual tonsils fill the valleculae and partially or fully obscure the view of the epiglottis. Friedman grading system consists of 0 to 4 scale: 0- complete absence of lymphoid tissue; 1- lymphoid tissue scattered over tongue base; 2- lymphoid tissue covering entirety of tongue base with limited vertical thickness; 3- significantly raised lymphoid tissue covering entirety of the tongue base, approximately 5 to 10 mm in thickness; 4- lymphoid tissue rising above the tip of the epiglottis, 10 or more mm in thickness.

    At baseline

Secondary Outcomes (14)

  • Sociodemographic factors: age

    At baseline

  • Sociodemographic factors: gender

    At baseline

  • Sociodemographic factors: body mass index (BMI)

    At baseline

  • Sociodemographic factors: occupation and employment status

    At baseline

  • Sociodemographic factors: health behaviors

    At baseline

  • +9 more secondary outcomes

Study Arms (2)

Lingual Tonsil Hypertrophy participants

EXPERIMENTAL

The research group consisted of 50 consecutive adult outpatients suffering from swallowing disorders, examined by otorhinolaryngologist at the Hospital of Lithuanian University of Health Sciences. Lingual Tonsil Hypertrophy was diagnosed using videolaryngoscopy.

Device: VideolaryngoscopyOther: Reflux Symptom Index QuestionnaireOther: Dysphagia Screening Questionnaire

Control participants

OTHER

The control group consisted of 50 healthy adult participants, who were examined using videolaryngoscopy and no pharyngeal pathologies were diagnosed, including lingual tonsil hypertrophy.

Device: VideolaryngoscopyOther: Reflux Symptom Index QuestionnaireOther: Dysphagia Screening Questionnaire

Interventions

VideolaryngoscopyDEVICE

A rigid 70 degree laryngoscope is inserted into the subject's oropharynx, which allows to visualize the lingual tonsils. The size of the lingual tonsils is evaluated using DelGaudio and Friedman grading systems.

Control participantsLingual Tonsil Hypertrophy participants
Reflux Symptom Index QuestionnaireOTHER

A validated clinical tool for suspecting laryngopharyngeal reflux (LPR). The questionnaire was proposed by Belafsky et al. (2002) and consists of 9 most common gastroesophageal reflux disease (GERD) and LPR symptoms: hoarseness or a problem with your voice; clearing your throat; excess throat mucus or postnasal drip; difficulty swallowing food, liquids, or pills; coughing after you ate or after lying down; breathing difficulties or choking episodes; troublesome or annoying cough; sensation of something sticking in your throat or a lump in your throat; heartburn, chest pain, indigestion, or stomach acid coming up. Each symptom is evaluated on a scale from 0 to 5 (0 - no complaint, 5 - severe symptom). The sum of all symptom evaluations ranges from 0 to 45.

Control participantsLingual Tonsil Hypertrophy participants
Dysphagia Screening QuestionnaireOTHER

A validated questionnaire, proposed by Ohkuma et al. (2002). Lithuanian version of the questionnaire consists of 16 questions: choking during swallowing meals / liquids; difficulty eating solid foods; difficult swallowing; feeling of food getting stuck in the throat; longer than before eating time; feeling of food remaining in the mouth; feeling that food or liquid is going up into the throat from the stomach; feeling of food being stuck in the esophagus; weight loss; food getting stuck in the throat; food falling from the mouth; difficulty coughing during or after meals; occurrence of pneumonia; hoarseness; coughing during the night. Interpretation of dysphagia screening questionnaire: Advanced symptom - 2 points; Moderate intensity symptom - 1 point; No symptom - 0 point. At least one advanced symptom means - dysphagia. Higher score represents stronger dysphagia intensity. The maximum score is 32 points.

Control participantsLingual Tonsil Hypertrophy participants

Eligibility Criteria

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

You may qualify if:

  • Adults
  • Consent for participating in the research
  • No cognitive disorders or mental illnesses
  • Complaining about difficulty swallowing (research group)
  • Enlarged lingual tonsils on videolaryngoscopy (research group)
  • Generally healthy, no complaints of swallowing disorders (control group)
  • Normal-sized lingual tonsils (control group)

You may not qualify if:

  • Refusal to participate in the research
  • Younger than 18 and older than 80 years old
  • Serious mental or cognitive conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nora Siupsinskiene, Professor

    Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department

    PRINCIPAL INVESTIGATOR

  • Nora Siupsinskiene, Professor

    Klaipėda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor medical doctor of otorhinolaryngology

Study Record Dates

First Submitted

August 27, 2016

First Posted

October 6, 2016

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

LI(1)