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Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study

NCT ID: NCT01223859

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Snoring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

Interstitial soft palate RF surgery

Group Type EXPERIMENTAL

Interstitial soft palate surgery

Intervention Type PROCEDURE

Soft palate RF surgery in local anaesthesia

Interventions

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Interstitial soft palate surgery

Soft palate RF surgery in local anaesthesia

Intervention Type PROCEDURE

Other Intervention Names

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RFA RFTA

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany

UNKNOWN

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Dept of ORL HN Surgery

Principal Investigators

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Leif JJ Bäck, MD PhD

Role: STUDY_DIRECTOR

Helsinki University Dept of ORL HN Surg

References

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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.

Reference Type DERIVED
PMID: 21311985 (View on PubMed)

Other Identifiers

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lefa

Identifier Type: -

Identifier Source: org_study_id