Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study

Study Overview
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Brief Summary
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Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study

Detailed Description
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TABLE 1. The inclusion and exclusion criterion used for the multicenter study. Criteria Inclusion Exclusion _____________ Age (years) 18-65 < 18, > 65 Habitual snoring yes no Excessive daytime sleepiness no yes BMI (kg/m2) < 28 > 28 AHI (events/hour) < 15 > 15 Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue Size of palatine tonsils (grade) 0-II III-IV Nose breathing problems no yes Pharyngeal tonsil hypertrophy no yes A bed partner to assess snoring yes no _____________ Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

Official Title
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The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring

Conditions
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Snoring

Intervention / Treatment
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* Procedure: Interstitial soft palate surgery


Participation Criteria
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Eligibility Criteria
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TABLE 1. The inclusion and exclusion criterion used for the multicenter study. Criteria Inclusion Exclusion _____________ Age (years) 18-65 < 18, > 65 Habitual snoring yes no Excessive daytime sleepiness no yes BMI (kg/m2) < 28 > 28 AHI (events/hour) < 15 > 15 Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue Size of palatine tonsils (grade) 0-II III-IV Nose breathing problems no yes Pharyngeal tonsil hypertrophy no yes A bed partner to assess snoring yes no _____________ Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Interstitial soft palate RF surgery | Procedure: Interstitial soft palate surgery<br>* Soft palate RF surgery in local anaesthesia<br>* Other names: RFTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual analogue scale snoring patient and bed partner | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.