Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring
This date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)
Study Completion
March 2010
Actual (reported)
Brief Summary
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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
74 participants
Study completion date
March 2010
Actual (reported)
Listed locations
0 countries · 0 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
January 2008
Date type not reported
This date has not been verified as actual or estimated.
Visual analogue scale snoring patient and bed partner
3 months postoperatively
Study Arms (1)
intervention
EXPERIMENTAL
Interstitial soft palate RF surgery
Procedure: Interstitial soft palate surgery
Interventions
Interstitial soft palate surgeryProcedure
Soft palate RF surgery in local anaesthesia
Also known as: RFA, RFTA
intervention
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Eligibility Criteria
Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Back LJ, Koivunen P, Pyykko I, Stene BK, Makitie AA. The impact of pretreatment assessment of oropharynx on interstitial soft palate radiofrequency surgery outcome--a multi-center study in patients with habitual snoring. Sleep Breath. 2012 Mar;16(1):199-204. doi: 10.1007/s11325-011-0490-4. Epub 2011 Feb 12.
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Source: ClinicalTrials.gov.
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