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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926014
• Other study ID #: LTH1
• Status: Completed
• Phase: N/A
• First received: August 27, 2016
• Last updated: October 4, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Hypertrophy
• Lingual Tonsil Hypertrophy

Intervention

Device:
• Videolaryngoscopy
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.

Other:
• Reflux Symptom Index Questionnaire
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.
• Dysphagia Screening Questionnaire
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.

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Klaipeda University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sociodemographic factors: age	Participant's age in years at the time of the study.	At baseline	No
Secondary	Sociodemographic factors: gender	Gender: male/female.	At baseline	No
Secondary	Sociodemographic factors: body mass index (BMI)	Self-reported height and weight were used to calculate BMI (kg/m^2). Obesity was defined as a BMI value of 30 or higher, overweight as 25.0-29.9, normal weight as 18.5-24.9, and underweight as less than 18.5	At baseline	No
Secondary	Sociodemographic factors: occupation and employment status	Participants were asked about their job (job title). Occupations were classified as one of 4 categories: office worker; laborer; retired; disabled	At baseline	No
Secondary	Sociodemographic factors: health behaviors	Cigarette smoking status was categorised into 4 categories: "non smoker"; "smoker"; "former smoker"; "passive smoker". Lifetime alcohol drinking status was categorized according to the frequency of alcohol use as "never"; "several times a year"; "several times a month"; "several times a week".	At baseline	No
Secondary	Sociodemographic factors: previous tonsillectomy	Participants were asked if they had their palatal tonsils removed. if yes, they were asked how long ago it happened.	At baseline	No
Secondary	Sociodemographic factors: gastrointestinal diseases	The presence of gastrointestinal tract diseases was evaluated by asking participants if they were diagnosed with any disease of gastrointestinal tract. Most common were gastroesophageal reflux disease (GERD) and gastric/duodenal ulcers.	At baseline	No
Secondary	Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings	Data, found on FEGDS: erosive esophagitis (yes/no); hiatal hernia (yes/no); other gastric or duodenal pathologies.	At baseline	No
Secondary	Sociodemographic factors: use of antacids	We asked participants if they use antacid drugs, what kind of drug they use and the length of the use.	At baseline	No
Secondary	Sociodemographic factors: allergic diseases	History of allergic diseases: participants checked "yes" if they were diagnosed with an allergic disease; "no" if not.	At baseline	No
Secondary	General health status	General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).	At baseline	No
Secondary	Reflux Symptom Index questionnaire	A validated clinical tool for suspecting laryngopharyngeal reflux (LPR). The questionnaire 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.	At baseline	No
Secondary	Dysphagia Screening Questionnaire	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.	At baseline	No
Secondary	Symptom severity	Participants were asked to evaluate 8 most common LTH symptoms using visual analogue scale (10 cm line, where 0 cm- no symptom, 10 cm- extremely severe symptom). Symptoms: hoarseness; difficult swallowing; painful swallowing; sensation of something sticking in your throat or a lump in your throat; difficult breathing, shortness of breath; snoring; cough; pain in the neck, pharynx.	At baseline	No