Randomized Controlled Trial of TCRFVR and LAUP in Snorers - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

LAUP is more effective in eliminating snoring

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

However, Rf cause less post-operative discomfort

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Randomized Controlled Trial of TCRFVR and LAUP in Snorers

Official Title ^ICMJE

Comparison of Clinical Effect Between Temperature-Controlled Radio-Frequency Uvuloplasty and Laser Assisted Uvulo-Pharyngoplasty in Patients Who Snore

Brief Summary

We hypothesis that radiofrequency will cause less post-operative discomfort when compared with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into this study. After overnight sleep test confimred that no obstructive sleep apnea existed, cases were informed consented. Then they were randomized into two groups. Post-operative pain, duration of analgesics were recorded.

Detailed Description

Although Rf group was less effective, they felt less discomfort.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Snorer

Intervention ^ICMJE

Procedure: TCRFVR and LAUP

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

RDI < 5/h

Exclusion Criteria:

Previous treated snoring, coagulation disorder

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00202943

Responsible Party

Study ID Numbers ^ICMJE

911007, TCVGH-917003A

Study Sponsor ^ICMJE

Taichung Veterans General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Shih-An Liu, MD, MHA

Taichung Veterans General Hospital

Information Provided By

Taichung Veterans General Hospital

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP