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CTRI Number  CTRI/2017/10/010180 [Registered on: 24/10/2017] Trial Registered Prospectively
Last Modified On: 24/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Studying cough in people with swallowing difficulties after stroke. 
Scientific Title of Study   Analysis of cough in post stroke individuals with dysphagia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Carol Melanie Alvares 
Designation  PG Student 
Affiliation  School of Allied Health Science, Manipal University. 
Address  Department of Speech and Hearing SOAHS, Manipal University Manipal.

Dakshina Kannada
KARNATAKA
576104
India 
Phone  9964978491  
Fax    
Email  carol_alvares@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepa Devadiga 
Designation  Associate Professor 
Affiliation  Department of Speech and Hearing SOAHS, Manipal University Manipal. 
Address  Department of Speech and Hearing SOAHS, Manipal University Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9986447191  
Fax    
Email  deepa.n@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Deepa Devadiga 
Designation  Associate Professor 
Affiliation  Department of Speech and Hearing SOAHS, Manipal University Manipal. 
Address  Department of Speech and Hearing SOAHS, Manipal University Manipal.

Hassan
KARNATAKA
576104
India 
Phone  9986447191  
Fax    
Email  deepa.n@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal University Manipal, Karnataka. 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Speech and Hearing SOAHS, Manipal University Manipal. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Carol Melanie Alvares  Kasturba Medical College  Department of Speech and Hearing SOAHS, Manipal University Manipal.
Udupi
KARNATAKA 
9964978491

carol_alvares@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Kasturba Hospital, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stroke with Dysphagia adults.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  41.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals with acute post stroke (Brain stem and Non Brain stem lesions)
2. Adults in the age range of 41-60 years (Erikson’s stages of psychosocial development, 1968).
3. Individuals who are on tube dependent for feed
 
 
ExclusionCriteria 
Details  1. Tracheostomy/ Ventilator/ GCS less than 8
2. Neurodegenerative disorder, Gastrointestinal disorders
3. Unable to follow instructions (Aphasia/ Cognitive problems/ Hearing loss) 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Aim: To investigate the cough using acoustic analysis in individuals with dysphagia
OBJECTIVES:
To compare cough between pre and post swallow acoustically
To compare cough between pre and post swallow perceptually
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Aim: To investigate the cough using acoustic analysis in individuals with dysphagia
OBJECTIVES:
To compare cough between pre and post swallow acoustically
To compare cough between pre and post swallow perceptually
 
6 months
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Perry, L., & Love, C. P. (2001). Screening for dysphagia and aspiration in acute stroke: a systematic review. Dysphagia, 16(1), 7-18. Hinchey, J. A., Shephard, T., Furie, K., Smith, D., Wang, D., Tonn, S., & Stroke Practice Improvement Network Investigators. (2005). Formal dysphagia screening protocols prevent pneumonia. Stroke, 36(9), 1972-1976 Smithard, D. G., ONeill, P. A., England, R. E., Park, C. L., Wyatt, R., Martin, D. F., & Morris, J. (1997). The natural history of dysphagia following a stroke. Dysphagia, 12(4), 188-193. Leow LP, et al. The impact of dysphagia on quality of life in ageing and Parkinson’s disease asmeasured by the swallowing quality of life (SWAL-QOL) questionnaire. Dysphagia. 2010; 25(3):216–20.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Dysphagia is closely associated with stroke, and aspiration pneumonia is a main cause of death among stroke patients (Perry L, et al., 2001; Hinchey J. A, et al., 2005). Dysphagia and related complications increase length of acute stay and are associated with increased mortality, comorbidity, and increased health care costs (Smithard et al., 1997). In many neurogenic populations, dystussia (impaired cough) and dysphagia are present in parallel (Mann et al,2000; Vellas et al ,2000), a finding that is not surprising given the shared neural and anatomical substrates of respiration, cough and swallowing function (Gestreauet,al 1996; Pitts T et,al 2012; Troche et al, 2014).

An effective cough is critical in removing aspirated material from the airway during swallowing, particularly in patients with additional co-morbidities who are more susceptible to developing pulmonary sequelae. However off late the cough testing in the clinical swallowing evaluation has also been a recent topic of interest to provide information regarding mechanisms of airway safety and the physiologic ability of an individual to defend their airway (Smith Hammond CA, et al. 2001; Pitts T, et al.2008; Plowman EK, et al. 2016).

Currently, however, cough testing is not routinely incorporated in the CSE across all settings, although there are several investigations probed into the cough, its different types, aerodynamic analysis of cough. 

This study aims to investigate the cough using acoustic analysis in individuals with dysphagia.

A total of 30 participants will be recruited for the study and cough sample will be recorded before and after swallow  with an Olympus Linear Pcm LS-P2 Voice Recorder placed approximately 10cm from the participant’s mouth using the PRAAT software installed in the laptop. The participant will be instructed to cough voluntarily on three trials. The best cough sample will be used for both perceptual and acoustic analysis. 

Cough will be analysed perceptually on a rating scale. Objectively the cough samples will be analysed by computing the Mel-Frequency Cepstral Coefficients (MFCC) and its derivatives with the help of MATLAB tool.

 

 
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