Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:38 AM
Study NCT ID:
NCT01223859
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Sponsor:
University of Helsinki
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: