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

NCT01223859 | Completed

• 1 other identifier: lefa
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Conditions

Snoring

Keywords

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

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual analogue scale snoring patient and bed partner

  3 months postoperatively

Study Arms (1)

intervention

EXPERIMENTAL

Interstitial soft palate RF surgery

Procedure: Interstitial soft palate surgery

Interventions

Interstitial soft palate surgery PROCEDURE

Soft palate RF surgery in local anaesthesia

Also known as: RFA, RFTA

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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Sponsors & Collaborators

• University of Helsinki: lead
• Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany: collaborator
• Helsinki University Central Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 21311985 DERIVED

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leif JJ Bäck, MD PhD

  Helsinki University Dept of ORL HN Surg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: October 19, 2010

Record last verified: 2007-10