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Clinical Trials/NCT02926014
NCT02926014CompletedNot Applicable

Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms

Lithuanian University of Health Sciences1 site in 1 country100 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Lingual tonsil enlargement grade on videolaryngoscopy

Study Overview

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.

Detailed Description

Two groups of people were interviewed during this research - the LTH group and the control group - a total of 100 subjects. The first group was comprised of 50 individuals, who visited the otorhinolaryngologist at Lithuanian University of Health Sciences hospital, regarding dysphagia, and were diagnosed with LTH during endoscopy. The second group consisted of 50 healthy individuals without dysphagia, who did not have enlarged lingual tonsils during assessment using videolaryngoscopy. All subjects filled out the questionnaires, composed of RSI (Reflux Symptom Index) and DSQ (Dysphagia Screening Questionnaire) questionnaires, validated and verified for use in Lithuania, together with a questionnaire created specifically for this research for gathering sociodemographic data.

The LTH grade of all subjects was determined using DelGaudio and Friedman grading systems.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Videolaryngoscopy (Device)

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.

Intervention: Reflux Symptom Index Questionnaire (Other)

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.

Intervention: Dysphagia Screening Questionnaire (Other)

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.

Intervention: Videolaryngoscopy (Device)

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.

Intervention: Reflux Symptom Index Questionnaire (Other)

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.

Intervention: Dysphagia Screening Questionnaire (Other)

Outcomes

Primary Outcomes

Lingual tonsil enlargement grade on videolaryngoscopy

Time Frame: At baseline

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.

Secondary Outcomes

  • Sociodemographic factors: health behaviors(At baseline)
  • Sociodemographic factors: previous tonsillectomy(At baseline)
  • Sociodemographic factors: allergic diseases(At baseline)
  • General health status(At baseline)
  • Sociodemographic factors: age(At baseline)
  • Sociodemographic factors: gender(At baseline)
  • Sociodemographic factors: body mass index (BMI)(At baseline)
  • Sociodemographic factors: gastrointestinal diseases(At baseline)
  • Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings(At baseline)
  • Sociodemographic factors: occupation and employment status(At baseline)
  • Sociodemographic factors: use of antacids(At baseline)
  • Reflux Symptom Index questionnaire(At baseline)
  • Dysphagia Screening Questionnaire(At baseline)
  • Symptom severity(At baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nora Siupsinskiene

Professor medical doctor of otorhinolaryngology

Lithuanian University of Health Sciences

Study Sites (1)

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