- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01223859
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
Interstitial soft palate RF surgery
|
Soft palate RF surgery in local anaesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: 3 months postoperatively
|
Visual analogue scale snoring patient and bed partner
|
3 months postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Leif JJ Bäck, MD PhD, Helsinki University Dept of ORL HN Surg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEFA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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