Lingual Tonsil HypertrophyNCT02926014
Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
A study testing Videolaryngoscopy, Reflux Symptom Index Questionnaire and Dysphagia Screening Questionnaire in people with Lingual Tonsil Hypertrophy and Dysphagia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lingual Tonsil Hypertrophy, Dysphagia
- What is being tested?
- Videolaryngoscopy, Reflux Symptom Index Questionnaire and Dysphagia Screening Questionnaire
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- Oct 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Refusal to participate in the research
- Younger than 18 and older than 80 years old
- Serious mental or cognitive conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lingual Tonsil Hypertrophy, Dysphagia
- Being tested
- Videolaryngoscopy, Reflux Symptom Index Questionnaire, Dysphagia Screening Questionnaire
- Keywords
- Dysphagia, Lingual Tonsil Hypertrophy, Lingual Tonsil Enlargement
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopyDevice
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 QuestionnaireOther
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 QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Videolaryngoscopy; Other: Reflux Symptom Index Questionnaire; Other: Dysphagia Screening Questionnaire |
| 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. Receives: Device: Videolaryngoscopy; Other: Reflux Symptom Index Questionnaire; Other: Dysphagia Screening Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (14)
Sociodemographic factors: age
Participant's age in years at the time of the study.
Measured: At baseline
Sociodemographic factors: gender
Gender: male/female.
Measured: At baseline
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
Measured: At baseline
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
Measured: At baseline
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".
Measured: At baseline
Sociodemographic factors: previous tonsillectomy
Participants were asked if they had their palatal tonsils removed. if yes, they were asked how long ago it happened.
Measured: At baseline
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.
Measured: At baseline
Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings
Data, found on FEGDS: erosive esophagitis (yes/no); hiatal hernia (yes/no); other gastric or duodenal pathologies.
Measured: At baseline
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.
Measured: At baseline
Sociodemographic factors: allergic diseases
History of allergic diseases: participants checked "yes" if they were diagnosed with an allergic disease; "no" if not.
Measured: At baseline
General health status
General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).
Measured: At baseline
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.
Measured: At baseline
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.
Measured: At baseline
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lingual Tonsil HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Klaipėda University
- Responsible party
- Principal investigator, Nora Siupsinskiene, Lithuanian University of Health Sciences
- Investigators
- Nora Siupsinskiene, Professor, Principal investigator, Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology departmentNora Siupsinskiene, Professor, Principal investigator, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926014
- Sponsor's protocol ID
- LTH1
- Status last verified
- Oct 2016
- First submitted
- 27 Aug 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
- ClinicalTrials.gov ID
- NCT02926014
- Acronym / sponsor ID
- LTH1
- Conditions
- Lingual Tonsil Hypertrophy, Dysphagia
- Keywords
- Dysphagia, Lingual Tonsil Hypertrophy, Lingual Tonsil Enlargement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Klaipėda University
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lingual Tonsil Hypertrophy participants | Experimental | Device: Videolaryngoscopy, Other: Reflux Symptom Index Questionnaire, Other: Dysphagia Screening QuestionnaireThe 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. |
| Control participants | Other | Device: Videolaryngoscopy, Other: Reflux Symptom Index Questionnaire, Other: Dysphagia Screening QuestionnaireThe control group consisted of 50 healthy adult participants, who were examined using videolaryngoscopy and no pharyngeal pathologies were diagnosed, including lingual tonsil hypertrophy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Refusal to participate in the research
- Younger than 18 and older than 80 years old
- Serious mental or cognitive conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideolaryngoscopyA 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. | Device | Control participants, Lingual Tonsil Hypertrophy participants |
| Reflux Symptom Index QuestionnaireA 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. | Other | Control participants, Lingual Tonsil Hypertrophy participants |
| Dysphagia Screening QuestionnaireA 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. | Other | Control participants, Lingual Tonsil Hypertrophy participants |
Primary outcome
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.
14 secondary outcomes
Sociodemographic factors: age
Time frame: At baseline
Sociodemographic factors: gender
Time frame: At baseline
Sociodemographic factors: body mass index (BMI)
Time frame: At baseline
Sociodemographic factors: occupation and employment status
Time frame: At baseline
Sociodemographic factors: health behaviors
Time frame: At baseline
Sociodemographic factors: previous tonsillectomy
Time frame: At baseline
Sociodemographic factors: gastrointestinal diseases
Time frame: At baseline
Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings
Time frame: At baseline
Sociodemographic factors: use of antacids
Time frame: At baseline
Sociodemographic factors: allergic diseases
Time frame: At baseline
General health status
Time frame: At baseline
Reflux Symptom Index questionnaire
Time frame: At baseline
Dysphagia Screening Questionnaire
Time frame: At baseline
Symptom severity
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Siupsinskiene, Professor principal investigator
Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Nora Siupsinskiene, Professor principal investigator
Klaipėda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscopy, Reflux Symptom Index Questionnaire and Dysphagia Screening Questionnaire in people with Lingual Tonsil Hypertrophy and Dysphagia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lingual tonsil enlargement grade on videolaryngoscopy (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.