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Trial record 28 of 1348 for:    cough

Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02183519
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cough
Parkinson's Disease
Interventions: Drug: Capsaicin
Other: Voluntary cough test

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Parkinson's Disease = PD and Healthy Older Adult = HOA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
10 PD participants did not respond to 200micro-molar capsaicin, and received the 500 micro-molar single dose. 3/10 PD participants did not respond to 500, and thus did not produce analyzable data. Due to a computer error, data was lost for 3 of the HOA participants. Complete data sets were analyzed for 13 PD and 25 HOA participants.

Reporting Groups
  Description
Healthy Older Adults All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
Parkinson's Disease All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

Participant Flow:   Overall Study
    Healthy Older Adults   Parkinson's Disease
STARTED   28   16 
COMPLETED   25   13 
NOT COMPLETED   3   3 
computer error                3                0 
Did not respond to cough inducter                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Older Adults All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
Parkinson's Disease All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
Total Total of all reporting groups

Baseline Measures
   Healthy Older Adults   Parkinson's Disease   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   13   38 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  20.0%      2  15.4%      7  18.4% 
>=65 years      20  80.0%      11  84.6%      31  81.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  44.0%      6  46.2%      17  44.7% 
Male      14  56.0%      7  53.8%      21  55.3% 
Region of Enrollment 
[Units: Participants]
     
United States   25   13   38 


  Outcome Measures

1.  Primary:   Peak Expiratory Flow Rate   [ Time Frame: 1-2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Karen Hegland, PhD
Organization: University of Florida Communicative Disorders
phone: 352-273-3710
e-mail: kwheeler@ufl.edu


Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02183519     History of Changes
Other Study ID Numbers: IRB201400477
First Submitted: July 2, 2014
First Posted: July 8, 2014
Results First Submitted: February 2, 2017
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017