Comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control in patients with obstructive sleep apnea
Determination and comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control in patients referred to amiralam hospital clinic
Design
A randomized controlled trial clinical trial using foursquare blocked randomization and double blinds performed on 48 people
Settings and conduct
The evaluation of sleepiness during the day is recorded by the ESS questionnaire and neurocognitive assessment through the Digit Symbol Substitution Test. The severity of snoring is recorded by the VAS of 0-10. Pattern, level and severity of involvement are determined by drug-induced sleep-induced endoscopy (DISE) with propofol drip .Then the surgery plan is determined. The two groups are divided randomly by using the Foursquare blocked randomization. First, tonsillectomy and palatal suspension surgery are performed. Also RF is done. At the end of pharyngeal surgery, the surgeon is told whether to perform a hyoid suspension or not. About two months after surgery, patients undergo type 4 polysomnography to determine AHI. The severity of snoring after surgery is also recorded by VAS . The pattern, movement and collapse of the hypopharyngeal wall are assessed by DISE maneuver during fibropeptic and the results are compared with the preoperative one.
Participants/Inclusion and exclusion criteria
Inclusion criteria: AHI > 5 in polysomnography with complaint of obstructive sleep apnea symptoms.
Exclusion criteria: BMI > 35; past history of neck or OSA surgeries; metabolic or cardiovascular diseases; cooperative disinclination.
Intervention groups
Performing up 3 surgery with RF in all patients and performing additional hypothyroidism suspension surgery in the intervention group and not performing it in the control group.
Main outcome variables
Movement and collapse pattern of hypopharyngeal; intensity of snoring
General information
Reason for update
Acronym
DISE
IRCT registration information
IRCT registration number:IRCT20190602043791N2
Registration date:2021-02-11, 1399/11/23
Registration timing:prospective
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Reza Erfanian Azimzadeh Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6672 7061
Email address
r_erfanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control in patients with obstructive sleep apnea
Public title
Comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
AHI>5 in polysomnography with complaint of obstructive sleep apnea symptoms
Exclusion criteria:
BMI>35
past history of neck or OSA surgeries
metabolic or cardiovascular diseases
cooperative disinclination
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization type is blocked randomization. Foursquare blocks of intervention group (A) and control (B) are defined on cards 1-6 (AABB, ABAB, ABBA, BBAA, BABA, BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know whether he is in the intervention or control group, and the outcome assessor does not know whether hyoido-thyroid suspension has been performed for the patient or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Vice Chancellor for Research and Technology, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1399.037
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
Hypopnea apnea ratio index(AHI)
Timepoint
Before the study and two months after surgery
Method of measurement
Polysomnography test
Secondary outcomes
1
Description
Intensity of snoring
Timepoint
Before the study and two months after surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: obstructive apnea patients candidate for palatal suspension surgery who, after the end of pharyngeal surgery, the surgeon also performs hyoid suspension in patients in this group.
Category
Treatment - Surgery
2
Description
Control group: patients with obstructive sleep apnea who are candidates for palatal suspension surgery, but after pharyngeal surgery, the surgeon does not perform hyoid suspension in patients in this group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Alam hospital ENT clinic
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Street address
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
City
Tehran
Province
Tehran
Postal code
141765371
Phone
+98 21 6670 1768
Email
r_erfanian@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Position
َAssistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
City
Tehran
Province
Tehran
Postal code
141765371
Phone
+98 21 6670 6106
Email
rezakhosravimd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
rezakhosravimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
rezakhosravimd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available