Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Respiratory Load Magnitude Estimation in PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202057
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to determine whether people with Parkinson's disease (PD) experience reduced perception of respiratory resistive loads versus healthy adults in the same age group. Further, the study will determine whether people with PD and trouble swallowing experience even more reduction of their perception of a respiratory resistive load.

Condition or disease Intervention/treatment
Parkinson's Disease Aging Other: Respiratory resistive load on inhalation Other: Fluoroscopic swallowing evaluation

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's disease
Men and women with Parkinson's disease, between 45 and 85 years of age. The following will be done: Respiratory resistive load on inhalation and Fluoroscopic swallowing evaluation.
Other: Respiratory resistive load on inhalation
The participant will be seated in a chair, and will be instructed to "relax and breathe" through a facemask. Five respiratory resistive loads (5-40 cmH2O resistive pressure) will be applied between 3-5 times during inhalation. Following each loaded breath, participants will rate the perceived difficulty of breathing in.

Other: Fluoroscopic swallowing evaluation
Participants with PD only will receive a swallowing evaluation as part of their routine clinical care. Generally, the standard clinical evaluation protocol consists of multiple swallows of thin liquid barium, pudding-thick barium, and a cracker or cookie coated with barium. Results are reviewed by the treatment speech-language pathologist, and for the purposes of this study, the researchers will review the most recently recorded swallow study and identify the worst observed penetration-aspiration (PA) score.

Healthy adults
Men and women without Parkinson's disease, between 45 and 85 years of age. The following will be done: Respiratory resistive load on inhalation.
Other: Respiratory resistive load on inhalation
The participant will be seated in a chair, and will be instructed to "relax and breathe" through a facemask. Five respiratory resistive loads (5-40 cmH2O resistive pressure) will be applied between 3-5 times during inhalation. Following each loaded breath, participants will rate the perceived difficulty of breathing in.




Primary Outcome Measures :
  1. Perceived difficulty inhaling against each respiratory resistive load. [ Time Frame: Baseline ]
    Participants will rate the level of difficulty when inhaling against different levels of resistive load. The Borg scale ranges from 6-20, where 6 is 'no difficulty' and 20 is 'maximal difficulty.'


Secondary Outcome Measures :
  1. The amount of pressure generated while inhaling against each resistive load [ Time Frame: Baseline ]
    The mouth pressure will be measured while each participant is inhaling through the facemask, against each resistive load level. This will be measured in cmH2O


Other Outcome Measures:
  1. Total amount of air that can be expired from the lungs [ Time Frame: Baseline ]
    Spirometry will be used to determine the forced vital capacity, and forced expiratory volume in 1 second.

  2. The maximum amount of inspiratory pressure [ Time Frame: Baseline ]
    A manometer will be used to measure the maximum inspiratory pressure each participant can generate.

  3. Feelings of sadness or depression [ Time Frame: Baseline ]
    The Beck Depression Index (BDI) is a 21-item questionnaire that will be completed by each participant. Scores range from 1-10 (normal ups and downs) to over 40 (extreme depression).

  4. Feeling apathetic, or indifferent. [ Time Frame: Baseline ]
    The Marin apathy index (MAI) is a 14-item questionnaire with scores ranging from 0 (not at all) to 3 (a lot) for each item.

  5. Ability to swallow liquids and solids without material entering the airway [ Time Frame: Baseline ]
    The penetration-aspiration scale will be used by the investigators to determine whether material enters the airway during swallowing. This ranges from 1 (no penetration/aspiration) to 8 (silent aspiration).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include 2 participant groups: those with Parkinson's disease, and healthy age- matched control participants. We will recruit 40 healthy older adults and 40 individuals with PD to participate. We will recruit all participants with PD from those referred for swallowing evaluation by the speech-language pathology service at the University of Florida (UF) Center for Movement Disorders and Neurorestoration (CMDNR). Healthy participants will be recruited via the UF Institutional Review Board's (IRBs) Healthstreet program, and local/campus advertisements.
Criteria

Inclusion Criteria:

  • Between the ages of 45 and 85
  • Ability to provide informed consent
  • Patient group: Diagnosis of PD, Hoehn and Yahr stages II - IV, by a UF Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict UF brain bank criteria.
  • Healthy older adults: History of PD, or any other neurologic or neurodegenerative disease including stroke.

Exclusion Criteria:

  • History of head and neck cancer, and radiation treatment to the head or neck
  • History of breathing disorders or diseases (e.g. chronic obstructive pulmonary disease (COPD), asthma, lung cancer)
  • History of smoking in the past 5 years, or for more than 5 years at any one time
  • Severe cognitive deficits including dementia.
  • Difficulty complying with protocol due to severe neuropsychological disorder (i.e., severe depression: 31 or greater on the BDI)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202057


Locations
Layout table for location information
United States, Florida
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Layout table for investigator information
Principal Investigator: Karen W Hegland, PHD University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02202057    
Other Study ID Numbers: IRB201400183
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by University of Florida:
respiratory sensation
somatosensation
resistive load
magnitude estimation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases