Determination of patient's comfort in using mask with lidocaine-prilocaine gel compared to placebo and not using any gel
Design
Randomized control trial, with control group, parallel groups trial with triple blinded outcome assessment
Settings and conduct
The patient's discomfort with the mask being evaluated by the patient's VAS is recorded from 0 to 10 (with 4 cm water pressure and no leakage).
In the first group, after washing the face with soap and water and drying the face, a thick layer of cream is applied to the nasal bridge area (1.5 g per 10 cm 2) without entering the gel into eye. The applied surface is covered with a nylon. After 15 minutes the mask is re-inserted and the degree of discomfort after VAS is measured. The titration is then performed according to the AASM guideline.
Tomorrow morning, the VAS will again measured regarding to difficulty in using the mask. A person's tendency to use a mask documented from 1 to 5 and the extent of refreshment on following day documented from 1 to 5.
The scoring is then performed by a blind group to the study and the parameters such as the maximum pressure of CPAP has, REM percentages and sleep efficiency are measured. AHI of diagnostic polysomnography, REM percentages and sleep efficiency are also recorded along with BMI, age and sex questionnaires.
The same will apply to the control group using lubricant gel and the mask without any gel.
Participants/Inclusion and exclusion criteria
Patients who referred to Baharlou and Imam Khomeyni hospital for CPAP titration due to obstructive sleep apnea
Intervention groups
Use of lidocaine-prilocaine
Use of lubricant gel
Main outcome variables
The amount of patient is comfortably using the CPAP mask
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190602043791N1
Registration date:2019-11-12, 1398/08/21
Registration timing:prospective
Last update:2019-11-12, 1398/08/21
Update count:0
Registration date
2019-11-12, 1398/08/21
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
2019-11-21, 1398/08/30
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lidocaine-prilocaine cream on comfortably of CPAP mask in patients who undergone PAP-titration due to obstructive sleep apnea
Public title
lidocaine-prilocaine cream effect on comfortably of CPAP mask
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who refeered to Bharlou and Imam Khomeyni hospital for CPAP titration due to obstructive sleep apnea
Exclusion criteria:
Cardiac arrhythmia, Anti arrhythmic drug class III consumption, seizure, Methemoglobinemia, allergy to anesthesia solution, absence of informed consent
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block randomization was performed by the StatsDirect program with seed 10, number 69 and random block size between 2 and 4 and treatment number 3.
A B C code is required for each group. At night the technician (blind to AB groups) contact the code holder who is blind to each of the groups (CAB), to be informed for titration in order to use the gel in 1 or 2 or he should not use the gel.
It should be explained that in Group C no gel 1 or 2 is used, it is not possible to blind technicians and patients in this group.
The technician and the patient are blind to the type of material used. Gel 1 is a mixture of lidocaine prilocaine and 2 is lubricants.
Blinding (investigator's opinion)
Triple blinded
Blinding description
A B C code is required for each group. At night the technician (blind to AB groups) contact the code holder who is blind to each of the groups (CAB), to be informed for titration in order to use the gel in 1 or 2 or he should not use the gel.
It should be explained that in Group C no gel 1 or 2 is used, it is not possible to blind technicians and patients in this group.
The technician and the patient are blind to the type of material used. Gel 1 is a mixture of lidocaine prilocaine and 2 is lubricants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences
Street address
Baharloo Hospital, Behdari St, Railway Sq, and Tehran, Iran
City
Tehran
Province
Tehran
Postal code
12299
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.TUMS.VCR.REC.1398.552
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
G47.33
Primary outcomes
1
Description
comfortably of CPAP mask usage
Timepoint
Two times, immediately after putting CPAP mask and 15 minutes after applying gel
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who candidates for CPAP titration due to obstructive sleep apnea
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharlou hospital
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Street address
Baharloo Hospital, Behdari St, Railway Sq, and Tehran, Iran
City
Tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Email
Hosp_baharloo@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital complex
Full name of responsible person
Reza Erfanian Azimzadeh Khosravi
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
419733141
Phone
+98 21 6658 1587
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@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
Sa'adi Shomali Street, Darwazeh Doulat, the new building of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
1145755811
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
Sa'adi Shomali Street, Darwazeh Doulat, the new building of Amir Alam Hospital
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
Sa'adi Shomali Street, Darwazeh Doulat, the new building of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
rezakhosravimd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of data would be accessible
When the data will become available and for how long
In time of publishing the results
To whom data/document is available
Researchers in the field of sleep medicine
Under which criteria data/document could be used
For helping to treat sleep disorders
From where data/document is obtainable
ِDr Reza Erfanian
rezakhoravimd@gmail.com
What processes are involved for a request to access data/document