Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Primary Purpose
Lingual Tonsil Hypertrophy, Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Videolaryngoscopy
Reflux Symptom Index Questionnaire
Dysphagia Screening Questionnaire
Sponsored by
About this trial
This is an interventional screening trial for Lingual Tonsil Hypertrophy focused on measuring Dysphagia, Lingual Tonsil Hypertrophy, Lingual Tonsil Enlargement
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
Sites / Locations
- Lithuanian University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lingual Tonsil Hypertrophy participants
Control participants
Arm Description
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.
The control group consisted of 50 healthy adult participants, who were examined using videolaryngoscopy and no pharyngeal pathologies were diagnosed, including lingual tonsil hypertrophy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sociodemographic factors: age
Participant's age in years at the time of the study.
Sociodemographic factors: gender
Gender: male/female.
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
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
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".
Sociodemographic factors: previous tonsillectomy
Participants were asked if they had their palatal tonsils removed. if yes, they were asked how long ago it happened.
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.
Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings
Data, found on FEGDS: erosive esophagitis (yes/no); hiatal hernia (yes/no); other gastric or duodenal pathologies.
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.
Sociodemographic factors: allergic diseases
History of allergic diseases: participants checked "yes" if they were diagnosed with an allergic disease; "no" if not.
General health status
General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).
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.
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.
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.
Full Information
NCT ID
NCT02926014
First Posted
August 27, 2016
Last Updated
October 4, 2016
Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University
1. Study Identification
Unique Protocol Identification Number
NCT02926014
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lingual Tonsil Hypertrophy, Dysphagia
Keywords
Dysphagia, Lingual Tonsil Hypertrophy, Lingual Tonsil Enlargement
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lingual Tonsil Hypertrophy participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Control participants
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Videolaryngoscopy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Reflux Symptom Index Questionnaire
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dysphagia Screening Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lingual tonsil enlargement grade on videolaryngoscopy
Description
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.
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Sociodemographic factors: age
Description
Participant's age in years at the time of the study.
Time Frame
At baseline
Title
Sociodemographic factors: gender
Description
Gender: male/female.
Time Frame
At baseline
Title
Sociodemographic factors: body mass index (BMI)
Description
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
Time Frame
At baseline
Title
Sociodemographic factors: occupation and employment status
Description
Participants were asked about their job (job title). Occupations were classified as one of 4 categories: office worker; laborer; retired; disabled
Time Frame
At baseline
Title
Sociodemographic factors: health behaviors
Description
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".
Time Frame
At baseline
Title
Sociodemographic factors: previous tonsillectomy
Description
Participants were asked if they had their palatal tonsils removed. if yes, they were asked how long ago it happened.
Time Frame
At baseline
Title
Sociodemographic factors: gastrointestinal diseases
Description
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.
Time Frame
At baseline
Title
Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings
Description
Data, found on FEGDS: erosive esophagitis (yes/no); hiatal hernia (yes/no); other gastric or duodenal pathologies.
Time Frame
At baseline
Title
Sociodemographic factors: use of antacids
Description
We asked participants if they use antacid drugs, what kind of drug they use and the length of the use.
Time Frame
At baseline
Title
Sociodemographic factors: allergic diseases
Description
History of allergic diseases: participants checked "yes" if they were diagnosed with an allergic disease; "no" if not.
Time Frame
At baseline
Title
General health status
Description
General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).
Time Frame
At baseline
Title
Reflux Symptom Index questionnaire
Description
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.
Time Frame
At baseline
Title
Dysphagia Screening Questionnaire
Description
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.
Time Frame
At baseline
Title
Symptom severity
Description
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.
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Klaipėda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
Country
Lithuania
12. IPD Sharing Statement
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Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
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