- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926014
Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania
- Lithuanian University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lingual Tonsil Hypertrophy participants
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. |
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.
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.
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. |
Other: Control participants
The control group consisted of 50 healthy adult participants, who were examined using videolaryngoscopy and no pharyngeal pathologies were diagnosed, including lingual tonsil hypertrophy.
|
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.
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic factors: age
Time Frame: At baseline
|
Participant's age in years at the time of the study.
|
At baseline
|
Sociodemographic factors: gender
Time Frame: At baseline
|
Gender: male/female.
|
At baseline
|
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
|
At baseline
|
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
|
At baseline
|
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".
|
At baseline
|
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.
|
At baseline
|
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.
|
At baseline
|
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.
|
At baseline
|
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.
|
At baseline
|
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.
|
At baseline
|
General health status
Time Frame: At baseline
|
General health status was selfreported using visual analogue scale (0-excellent/ very good, 10-poor).
|
At baseline
|
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.
|
At baseline
|
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. |
At baseline
|
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.
|
At baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nora Siupsinskiene, Professor, Klaipėda university
- Principal Investigator: Nora Siupsinskiene, Professor, Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTH1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysphagia
-
Morinaga Milk Industry Co., LTDHospital de MataróRecruitingDysphagia | Swallowing Disorder | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia, OropharyngealSpain
-
All India Institute of Medical Sciences, New DelhiRecruitingOropharyngeal Dysphagia | Dysphagia, Late Effect of Stroke | Transfer Dysphagia | Cricopharyngeus Muscle DysfunctionIndia
-
National Taiwan University HospitalRecruitingDysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationTaiwan
-
University of Southern CaliforniaRecruitingDysphagia | Pharyngeal Dysphagia | Oral Pharyngeal DysphagiaUnited States
-
Peter Belafsky, MDTerminatedDysphagia | Oropharyngeal Dysphagia (OPD)United States
-
Atlantic Health SystemRecruitingPost Extubation DysphagiaUnited States
-
University of California, DavisCalifornia Institute for Regenerative Medicine (CIRM); Cook MyoSiteRecruitingOropharyngeal DysphagiaUnited States
-
University of British ColumbiaB.C. Rehabilitation FoundationCompletedThin Liquid DysphagiaCanada
-
Umm Al-Qura UniversityCompleted
-
NestléCompleted
Clinical Trials on Videolaryngoscopy
-
Campus Bio-Medico UniversityCompletedIntubation; Difficult or FailedItaly
-
Ajou University School of MedicineCompletedIntubationKorea, Republic of
-
Inonu UniversityCompletedIntraocular PressureTurkey
-
Diskapi Teaching and Research HospitalCompleted
-
Diskapi Teaching and Research HospitalCompleted
-
Université de MontréalCentre d'Apprentissage des Habiletés Cliniques (CAAHC); Laboratoire d'anatomie...CompletedSimulation | Cadaver | Intubation; Difficult or Failed | Hemoptysis | LaryngoscopeCanada
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingRespiratory Failure | Cardio Respiratory Arrest | Indication of Orotracheal Intubation | Neurological Failure
-
University of California, DavisRecruiting
-
Universitätsklinikum Hamburg-EppendorfCompleted