Back to resultsPretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Primary Purpose
Snoring
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interstitial soft palate surgery
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
Interstitial soft palate RF surgery
Outcomes
Primary Outcome Measures
VAS
Visual analogue scale snoring patient and bed partner
Secondary Outcome Measures
Full Information
NCT ID
NCT01223859
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
University of Helsinki
Collaborators
Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany, Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01223859
Brief Title
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany, Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Interstitial soft palate RF surgery
Intervention Type
Procedure
Intervention Name(s)
Interstitial soft palate surgery
Other Intervention Name(s)
RFA, RFTA
Intervention Description
Soft palate RF surgery in local anaesthesia
Primary Outcome Measure Information:
Title
VAS
Description
Visual analogue scale snoring patient and bed partner
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif JJ Bäck, MD PhD
Organizational Affiliation
Helsinki University Dept of ORL HN Surg
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21311985
Citation
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.
Results Reference
derived
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Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
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