Snoring Clinical Trial
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
Verified date | October 2007 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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
Status | Completed |
Enrollment | 74 |
Est. completion date | March 2010 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Helsinki University Central Hospital, Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS | Visual analogue scale snoring patient and bed partner | 3 months postoperatively | No |
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