Clinical trial NCT02926014: Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Official title: Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lingual Tonsil Hypertrophy
Dysphagia
Keywords: Dysphagia
Lingual Tonsil Hypertrophy
Lingual Tonsil Enlargement
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Klaipėda University
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Lingual tonsil enlargement grade on videolaryngoscopy
timeFrame: At baseline
Secondary outcomes:
measure: Sociodemographic factors: age
timeFrame: At baseline
measure: Sociodemographic factors: gender
timeFrame: At baseline
measure: Sociodemographic factors: body mass index (BMI)
timeFrame: At baseline
measure: Sociodemographic factors: occupation and employment status
timeFrame: At baseline
measure: Sociodemographic factors: health behaviors
timeFrame: At baseline
measure: Sociodemographic factors: previous tonsillectomy
timeFrame: At baseline
measure: Sociodemographic factors: gastrointestinal diseases
timeFrame: At baseline
measure: Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings
timeFrame: At baseline
measure: Sociodemographic factors: use of antacids
timeFrame: At baseline
measure: Sociodemographic factors: allergic diseases
timeFrame: At baseline
measure: General health status
timeFrame: At baseline
measure: Reflux Symptom Index questionnaire
timeFrame: At baseline
measure: Dysphagia Screening Questionnaire
timeFrame: At baseline
measure: Symptom severity
timeFrame: At baseline
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Klaipėda University
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
References: