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Register:	ClinicalTrials.gov
Last refreshed on:	17 October 2016
Main ID:	NCT02926014
Date of registration:	27/08/2016
Prospective Registration:	No
Primary sponsor:	Lithuanian University of Health Sciences
Public title:	Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Scientific title:	Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms
Date of first enrolment:	October 2014
Target sample size:	100
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02926014
Study type:	Interventional
Study design:	Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Phase:	N/A

Countries of recruitment
Lithuania

Contacts

Name:	Nora Siupsinskiene, Professor
Address:
Telephone:
Email:
Affiliation:	Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department

Name:	Nora Siupsinskiene, Professor
Address:
Telephone:
Email:
Affiliation:	Klaipeda University

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lingual Tonsil Hypertrophy

Dysphagia

Intervention(s)

Other: Reflux Symptom Index Questionnaire

Device: Videolaryngoscopy

Other: Dysphagia Screening Questionnaire

Primary Outcome(s)

Lingual tonsil enlargement grade on videolaryngoscopy [Time Frame: At baseline]

Secondary Outcome(s)

General health status [Time Frame: At baseline]

Reflux Symptom Index questionnaire [Time Frame: At baseline]

Sociodemographic factors: gender [Time Frame: At baseline]

Sociodemographic factors: use of antacids [Time Frame: At baseline]

Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings [Time Frame: At baseline]

Sociodemographic factors: previous tonsillectomy [Time Frame: At baseline]

Sociodemographic factors: body mass index (BMI) [Time Frame: At baseline]

Sociodemographic factors: gastrointestinal diseases [Time Frame: At baseline]

Sociodemographic factors: health behaviors [Time Frame: At baseline]

Dysphagia Screening Questionnaire [Time Frame: At baseline]

Sociodemographic factors: age [Time Frame: At baseline]

Sociodemographic factors: occupation and employment status [Time Frame: At baseline]

Symptom severity [Time Frame: At baseline]

Sociodemographic factors: allergic diseases [Time Frame: At baseline]

Secondary ID(s)

LTH1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Klaipeda University

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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