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Completed

NCT Number: NCT02926014

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

videolaryngoscopy

Device

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.

Reflux Symptom Index Questionnaire

Other

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

Other

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 outcomes

  1. 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

  1. Sociodemographic factors: age

    Time frame: At baseline

    Participant's age in years at the time of the study.

  2. Sociodemographic factors: gender

    Time frame: At baseline

    Gender: male/female.

  3. Sociodemographic factors: body mass index (BMI)

    Time frame: At baseline

    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

  4. Sociodemographic factors: occupation and employment status

    Time frame: At baseline

    Participants were asked about their job (job title). Occupations were classified as one of 4 categories: office worker; laborer; retired; disabled

  5. Sociodemographic factors: health behaviors

    Time frame: At baseline

    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".

  6. Sociodemographic factors: previous tonsillectomy

    Time frame: At baseline

    Participants were asked if they had their palatal tonsils removed. if yes, they were asked how long ago it happened.

  7. Sociodemographic factors: gastrointestinal diseases

    Time frame: At baseline

    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.

  8. Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings

    Time frame: At baseline

    Data, found on FEGDS: erosive esophagitis (yes/no); hiatal hernia (yes/no); other gastric or duodenal pathologies.

  9. Sociodemographic factors: use of antacids

    Time frame: At baseline

    We asked participants if they use antacid drugs, what kind of drug they use and the length of the use.

  10. Sociodemographic factors: allergic diseases

    Time frame: At baseline

    History of allergic diseases: participants checked "yes" if they were diagnosed with an allergic disease; "no" if not.

  11. General health status

    Time frame: At baseline

    General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).

  12. Reflux Symptom Index questionnaire

    Time frame: At baseline

    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.

  13. Dysphagia Screening Questionnaire

    Time frame: At baseline

    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.

  14. Symptom severity

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Klaipėda University

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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