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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01223859
Enrollment
74
Registered
2010-10-19
Start date
2008-01-31
Completion date
2010-03-31
Last updated
2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Snoring

Keywords

Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.

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.

Interventions

PROCEDUREInterstitial soft palate surgery

Soft palate RF surgery in local anaesthesia

Sponsors

Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany
CollaboratorUNKNOWN
Helsinki University Central Hospital
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
VAS3 months postoperativelyVisual analogue scale snoring patient and bed partner

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026