The purpose of this study was to assess the comparative effect of simultaneous uvulopalatopharyngoplasty and Radio-Frequency treatment with surgery alone for reducing of the upper airway obstruction as well as decreasing or eliminating the snoring in affected patients. This randomized clinical trial was conducted during 2009-2010. The inclusion criteria were as follows: existence of indications for surgery such as daytime sleepiness, daily dysfunction, obstructive sleep apnea with an apnea index, hypopnea over 15, patients with snoring and obstructive sleep apnea which have not improved despite the medical treatments and has tonsils with grade III or IV, and the person also agreed to participate in the study. A total number of 46 patients were consecutively assigned into two groups. The first group underwent uvulopalatopharyngoplasty, whereas the second group received Radio-Frequency in addition to uvulopalatopharyngoplasty. The severity of snoring and sleepiness in patients were recorded before and after the surgery in accordance with a checklist, then the obtained results were compared. The Visual Analogue Scale according to the patient's companion idea was used for assessment of the patient snoring status. The Epworth Sleepiness Scale questionnaire was also used to determine the sleepiness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204029355N1
Registration date:2012-04-14, 1391/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-14, 1391/01/26
Registrant information
Name
Asadolah Asadian
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 1221 3924
Email address
asadian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Isfahan University of Medical Sciences
Expected recruitment start date
2009-11-05, 1388/08/14
Expected recruitment end date
2011-03-10, 1389/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of surgery and surgery along with radio-frequency in the improvement of patients with nocturnal snoring in Isfahan, Iran
Public title
The effect of adding Radio-frequency to the surgery in snoring treatment
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: existence of indications for surgery including daytime sleepiness ; daily dysfunction; obstructive sleep apnea with an apnea index; hypopnea over 15; patients with snoring; obstructive sleep apnea which have not improved despite the medical treatments; has tonsils with grade III or IV; the person also agreed to participate in the study.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar-jarib St., Azadi Sq., Isfahan, Iran
City
Isfahan
Postal code
Approval date
2009-11-04, 1388/08/13
Ethics committee reference number
388391
Health conditions studied
1
Description of health condition studied
snoring
ICD-10 code
R06.5
ICD-10 code description
mouth breathing
Primary outcomes
1
Description
snoring
Timepoint
before and three months after surgery
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
daytime sleepiness
Timepoint
befor and three months after surgery
Method of measurement
اThe Epworth Sleepiness Scale (ESS
Intervention groups
1
Description
All of the patients in control group were initially tonsillectomy and then mucosa and sub-mucosa of soft palate were debridement and the palatoglossus and palatopharyngeus muscles were preserved as much as possible and the uvula was shortened and the tip of uvula brought out and then the soft palate returned toward the front and top and a portion of the anterior and posterior parts of the tonsils were removed to create more space. The location of the surgery stitches and restored.
Category
Treatment - Surgery
2
Description
All of the patients in interventional group were initially tonsillectomy and then mucosa and sub-mucosa of soft palate were debridement and the palatoglossus and palatopharyngeus muscles were preserved as much as possible and the uvula was shortened and the tip of uvula brought out and then the soft palate returned toward the front and top and a portion of the anterior and posterior parts of the tonsils were removed to create more space. The location of the surgery stitches and restored and then RF was done in the remaining parts. RF settings were based on individuals' anatomy. Power setting for soft palate in 5 points with regular intervals at the center of soft palate was 12 W. With 12 W of power RF in 6 to 8 points with a distance of one cm for base of tongue was used depending on the size of it. With 15 W of power RF was used for inferior turbinate in superior, posterior and lateral directions with a distance of one cm from each other.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Dr Asadolah Asadian
Street address
Alzahra University Hospital, Sofeh boulevard, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Isfahan university of Medical Sciences
Full name of responsible person
Dr Taleb Azarm
Street address
Research Department, Isfahan University of Medical Sciences, hezar-jarib St., Azadi Sq., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Isfahan university of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr S.Soheilipour
Position
Associated Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar-jarib St., Azadi Sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1627 6173
Fax
Email
soheilipour@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Dr Asadolah Asadian
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar-jarib St., Azadi Sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1221 3924
Fax
Email
asadian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Roya Taleban
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
00
Fax
Email
royataleban@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)