Status:
COMPLETED
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany
Helsinki University Central Hospital
Conditions:
Snoring
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 Excessi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01223859
Start Date
January 1 2008
End Date
March 1 2010
Last Update
October 19 2010
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