Effects of CPAP therapy on hypernasal speech in non cleft velopharyngeal dysfunction
Design
This study is a single subject study design that will be performed on a patient with noncleft velopharyngeal dysfunction.
Settings and conduct
This study will be performed in the cleft lip and palate clinic of Isfahan University of Medical Sciences.
This study has three phases:
Baseline phase: Perceptual assessments of speech and nasometery are performed weekly for one month.
Treatment Phase:CPAP treatment is done according to Dr. Kuehn's protocol within two months.Perceptual assessments of speech and nasometery are performed weekly.
Follow up phase: Perceptual assessments of speech and nasometery are performed weekly for one month.
Participants/Inclusion and exclusion criteria
Non cleft velopharyngeal dysfunction؛ No occult submucous cleft palate؛ Mild or moderate hypernasality؛ No compensatory error؛ No hearing loss and ear dysfunction
Intervention groups
This study has no control group. CPAP treatment will be performed for two months according to Dr. Kuehn's protocol.
Main outcome variables
Hypernasality of speech؛ Nasalanse score of speech
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201223049809N1
Registration date:2021-02-08, 1399/11/20
Registration timing:registered_while_recruiting
Last update:2021-02-08, 1399/11/20
Update count:0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Fatemeh Mostajeran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 1405
Email address
f.mostajeran@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of Continuous Positive Airway Pressure (CPAP) therapy on noncleft velopharyngeal dysfunction
Public title
Effects of CPAP therapy on hypernasal speech
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non cleft velopharyngeal dysfunction
Mild or moderate hypernasality
Exclusion criteria:
No occult submucouse cleft palate
No compensatory errors
No hearing loss and ear dysfunction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Method of the study is single subject design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
سامانه ملی اخلاق در پژوهش های زیست پزشکی
Street address
No. 7, Sarvestan St., Jeyshir Ave.
City
Isfahan
Province
Isfehan
Postal code
8158165166
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.MUI.MED.REC.1399.691
Health conditions studied
1
Description of health condition studied
Non cleft velopharyngeal dysfunction Hypernasal speech
ICD-10 code
MA82.2 Nas
ICD-10 code description
Nasality (or resonance) refers to the quality of the voice that is determined by the balance of sound vibration in the oral, nasal, and pharyngeal cavities during speech. Abnormal resonance can occur when there is obstruction in one of the cavities, causi
Primary outcomes
1
Description
Hypernasality of speech
Timepoint
At the beginning of the study and then weekly for three months
Method of measurement
CAPS Test
Secondary outcomes
1
Description
Nasalance score
Timepoint
At the beginning of the study and then weekly for three months
Method of measurement
Nasometer
Intervention groups
1
Description
Intervention group: Continuous positive air pressure (CPAP) treatment using CPAP device ( Resmed- S9) according to Dr. Kuehne protocol, 6 days a week for two months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک شکاف لب و کام اصفهان
Full name of responsible person
Fatemeh Khanlar
Street address
Rehabilitation institute, Isfahan univerity of medical sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5224
Email
cleftresearchcenter@gmail.com
Web page address
https://icct.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjouy Javanmard
Street address
Isfahan university of medical sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mostajeran
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 7, Sarvestan St., Jeyshir Ave.
City
Isfahan
Province
Isfehan
Postal code
8158165166
Phone
+98 31 3263 1406
Email
f.mostajeran@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mostajeran
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 7, Sarvestan St., Jeyshir Ave.
City
Isfahan
Province
Isfehan
Postal code
8158165166
Phone
+98 31 3263 1405
Email
f.mostajeran@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mostajeran
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Rehabilitation Institute,Isfahan university of medical sciences, Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5217
Email
f.mostajeran@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