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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01223859
Other study ID # lefa
Secondary ID
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


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
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