Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
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Purpose
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
| Condition | Intervention |
|---|---|
|
Snoring |
Procedure: Interstitial soft palate surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring |
- VAS [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]Visual analogue scale snoring patient and bed partner
| Enrollment: | 74 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: intervention
Interstitial soft palate RF surgery
|
Procedure: Interstitial soft palate surgery
Soft palate RF surgery in local anaesthesia
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Study Director: | Leif JJ Bäck, MD PhD | Helsinki University Dept of ORL HN Surg |
More Information
No publications provided by Helsinki University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Leif Bäck MD, PhD, Dept of ORL HN Surgery |
| ClinicalTrials.gov Identifier: | NCT01223859 History of Changes |
| Other Study ID Numbers: | lefa |
| Study First Received: | October 18, 2010 |
| Last Updated: | October 18, 2010 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Helsinki University:
|
Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate. |
Additional relevant MeSH terms:
|
Snoring Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013