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

Snoring Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223859
• Other study ID #: lefa
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2007
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Snoring

Intervention

Procedure:
• Interstitial soft palate surgery
Soft palate RF surgery in local anaesthesia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University	Helsinki University Central Hospital, Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual analogue scale snoring patient and bed partner	3 months postoperatively	No