<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202057</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400183</org_study_id>
    <nct_id>NCT02202057</nct_id>
  </id_info>
  <brief_title>Respiratory Load Magnitude Estimation in PD</brief_title>
  <official_title>Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether people with Parkinson's disease (PD)&#xD;
      experience reduced perception of respiratory resistive loads versus healthy adults in the&#xD;
      same age group. Further, the study will determine whether people with PD and trouble&#xD;
      swallowing experience even more reduction of their perception of a respiratory resistive&#xD;
      load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental design and procedures: This prospective experimental study will be completed in&#xD;
      one study visit taking between 1 and 3 hours. Verbal and written informed consent will be&#xD;
      obtained by qualified members of the investigative team. Following informed consent, all&#xD;
      participants will complete a health history questionnaire to assess inclusion/exclusion&#xD;
      criteria. For patients with PD the consenting investigator will review the electronic medical&#xD;
      record to ensure inclusion/exclusion criteria are met.&#xD;
&#xD;
      The experimental protocol will consist of 1.) Baseline pulmonary function measures, 2.)&#xD;
      Baseline measures of depression and apathy, 3.) Presentation of resistive inspiratory loads&#xD;
      via respiratory equipment, and 4.) Rating the perceived magnitude of respiratory sensations&#xD;
      as measured on a modified Borg scale (ranging from 6 - no breathing difficulty - to 20 -&#xD;
      maximal difficulty). For patients with PD only, the investigators will also review results of&#xD;
      the rehabilitation barium swallow study performed as part of their standard clinical care.&#xD;
&#xD;
      Baseline Pulmonary function measures: The forced expired volume in the first second (FEV1) of&#xD;
      a forced vital capacity (FVC) exhalation will be measured for each participant. Maximum&#xD;
      inspiratory pressure (PiMax) will be measured with a manometer. The PiMax test will be&#xD;
      repeated until 3 measurements within 10% variation are obtained, with at least 1 minute rest&#xD;
      between trials.&#xD;
&#xD;
      Baseline depression and apathy: There is a significant impact for emotion on respiratory&#xD;
      perceptual ratings. As such, we will measure baseline depression and apathy scores using 2&#xD;
      validated scales, the Beck Depression Index (BDI) and Marin Apathy Index (MAI). These are not&#xD;
      outcome measures, but will be used to determine exclusion criteria.&#xD;
&#xD;
      Should depression (17 or greater on BDI) be detected in a participant, that participant will&#xD;
      be provided with contact information for the University of Florida (UF) psychiatry and&#xD;
      psychology clinic and encouraged to seek further evaluation. In the case severe depression is&#xD;
      detected (31 or greater on BDI) the participant will not continue with the study, and will be&#xD;
      provided with contact information for the UF psychiatry and psychology clinic and encouraged&#xD;
      to seek further evaluation.&#xD;
&#xD;
      Inspiratory resistive load presentation:&#xD;
&#xD;
      The participant will be seated in a chair, separated from the investigator and experimental&#xD;
      apparatus. The participant will be instructed to &quot;relax and breathe&quot; through a facemask&#xD;
      connected to a non-rebreathing valve in line with a differential pressure transducer. The&#xD;
      inspiratory port of the valve will be connected to the resistive loading manifold. The&#xD;
      manifold consists of 5 differential resistors ranging from 5 - 40 centimeters/water (cmH2O)&#xD;
      of resistive pressure, separated by stoppered ports, as well as a no load condition. The load&#xD;
      is applied by removing the stop for an entire inspiratory breath, and then replacing the port&#xD;
      to continue resting tidal breathing. The pressure transducer will provide measures of mouth&#xD;
      pressure and airflow, which will be digitized and recorded to a desk top computer using&#xD;
      LabChart software. Following each loaded breath, the participant will provide an estimate of&#xD;
      the perceived difficulty of breathing using a modified Borg scale.&#xD;
&#xD;
      Participants will be familiarized with the loads in a practice session prior to initiating&#xD;
      the experimental protocol. During the experimental session, participants will listen to music&#xD;
      of their choice in order to mask experimental sounds. The resistive loads will be applied in&#xD;
      a randomized block design, with each loaded breath separated by at least three unloaded&#xD;
      breaths. Two blocks will be completed with each load presented between 3 and 5 times within&#xD;
      each block. Therefore, there will be a total of between 15 and 25 loaded breaths (3-5 loads x&#xD;
      5 presentations) per block. Participants will be instructed that when they see a small light&#xD;
      flash briefly on the table in front of them (which they will be familiarized with prior to&#xD;
      beginning the experiment) a resistive load will be applied to the next breath. Following the&#xD;
      loaded breath, the participant will be asked to estimate the perceived difficulty of&#xD;
      breathing on the Borg scale.&#xD;
&#xD;
      Rehabilitation barium swallow study: Participants with PD who are referred for a&#xD;
      rehabilitation barium swallowing evaluation will be recruited for this study. Therefore, the&#xD;
      swallowing evaluation is part of the normal clinical care of the patients and may vary based&#xD;
      on the clinical necessity as judged by the treating speech-language pathologist. Generally,&#xD;
      the standard clinical evaluation protocol consists of multiple swallows of thin liquid&#xD;
      barium, pudding-thick barium, and a cracker or cookie coated with barium. For the purposes of&#xD;
      this study, the researchers will review the most recently recorded swallow study and identify&#xD;
      the worst observed penetration-aspiration (PA) score (ranging from 1-8, where 1 is no&#xD;
      penetration or aspiration, and 8 is silent aspiration). The PA score will be recorded in&#xD;
      order to determine whether the participant has trouble swallowing (scores of 3-8) or not&#xD;
      (scores of 1 and 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived difficulty inhaling against each respiratory resistive load.</measure>
    <time_frame>Baseline</time_frame>
    <description>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.'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of pressure generated while inhaling against each resistive load</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total amount of air that can be expired from the lungs</measure>
    <time_frame>Baseline</time_frame>
    <description>Spirometry will be used to determine the forced vital capacity, and forced expiratory volume in 1 second.</description>
  </other_outcome>
  <other_outcome>
    <measure>The maximum amount of inspiratory pressure</measure>
    <time_frame>Baseline</time_frame>
    <description>A manometer will be used to measure the maximum inspiratory pressure each participant can generate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Feelings of sadness or depression</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Feeling apathetic, or indifferent.</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ability to swallow liquids and solids without material entering the airway</measure>
    <time_frame>Baseline</time_frame>
    <description>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).</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Parkinson's disease</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>Men and women without Parkinson's disease, between 45 and 85 years of age. The following will be done: Respiratory resistive load on inhalation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory resistive load on inhalation</intervention_name>
    <description>The participant will be seated in a chair, and will be instructed to &quot;relax and breathe&quot; 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.</description>
    <arm_group_label>Healthy adults</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluoroscopic swallowing evaluation</intervention_name>
    <description>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.</description>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include 2 participant groups: those with Parkinson's disease, and healthy&#xD;
        age- matched control participants. We will recruit 40 healthy older adults and 40&#xD;
        individuals with PD to participate. We will recruit all participants with PD from those&#xD;
        referred for swallowing evaluation by the speech-language pathology service at the&#xD;
        University of Florida (UF) Center for Movement Disorders and Neurorestoration (CMDNR).&#xD;
        Healthy participants will be recruited via the UF Institutional Review Board's (IRBs)&#xD;
        Healthstreet program, and local/campus advertisements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 45 and 85&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Patient group: Diagnosis of PD, Hoehn and Yahr stages II - IV, by a UF Movement&#xD;
             Disorders fellowship trained neurologist having completed a clinical assessment of&#xD;
             each participant's PD severity and arriving at the diagnosis of PD by applying strict&#xD;
             UF brain bank criteria.&#xD;
&#xD;
          -  Healthy older adults: History of PD, or any other neurologic or neurodegenerative&#xD;
             disease including stroke.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of head and neck cancer, and radiation treatment to the head or neck&#xD;
&#xD;
          -  History of breathing disorders or diseases (e.g. chronic obstructive pulmonary disease&#xD;
             (COPD), asthma, lung cancer)&#xD;
&#xD;
          -  History of smoking in the past 5 years, or for more than 5 years at any one time&#xD;
&#xD;
          -  Severe cognitive deficits including dementia.&#xD;
&#xD;
          -  Difficulty complying with protocol due to severe neuropsychological disorder (i.e.,&#xD;
             severe depression: 31 or greater on the BDI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen W Hegland, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Center for Movement Disorders and Neurorestoration</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>September 16, 2016</last_update_submitted>
  <last_update_submitted_qc>September 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>respiratory sensation</keyword>
  <keyword>somatosensation</keyword>
  <keyword>resistive load</keyword>
  <keyword>magnitude estimation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202057
org study id: IRB201400183
nct id: NCT02202057
lead sponsor: 
has dmc: No
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.
Experimental design and procedures: This prospective experimental study will be completed in
      one study visit taking between 1 and 3 hours. Verbal and written informed consent will be
      obtained by qualified members of the investigative team. Following informed consent, all
      participants will complete a health history questionnaire to assess inclusion/exclusion
      criteria. For patients with PD the consenting investigator will review the electronic medical
      record to ensure inclusion/exclusion criteria are met.

      The experimental protocol will consist of 1.) Baseline pulmonary function measures, 2.)
      Baseline measures of depression and apathy, 3.) Presentation of resistive inspiratory loads
      via respiratory equipment, and 4.) Rating the perceived magnitude of respiratory sensations
      as measured on a modified Borg scale (ranging from 6 - no breathing difficulty - to 20 -
      maximal difficulty). For patients with PD only, the investigators will also review results of
      the rehabilitation barium swallow study performed as part of their standard clinical care.

      Baseline Pulmonary function measures: The forced expired volume in the first second (FEV1) of
      a forced vital capacity (FVC) exhalation will be measured for each participant. Maximum
      inspiratory pressure (PiMax) will be measured with a manometer. The PiMax test will be
      repeated until 3 measurements within 10% variation are obtained, with at least 1 minute rest
      between trials.

      Baseline depression and apathy: There is a significant impact for emotion on respiratory
      perceptual ratings. As such, we will measure baseline depression and apathy scores using 2
      validated scales, the Beck Depression Index (BDI) and Marin Apathy Index (MAI). These are not
      outcome measures, but will be used to determine exclusion criteria.

      Should depression (17 or greater on BDI) be detected in a participant, that participant will
      be provided with contact information for the University of Florida (UF) psychiatry and
      psychology clinic and encouraged to seek further evaluation. In the case severe depression is
      detected (31 or greater on BDI) the participant will not continue with the study, and will be
      provided with contact information for the UF psychiatry and psychology clinic and encouraged
      to seek further evaluation.

      Inspiratory resistive load presentation:

      The participant will be seated in a chair, separated from the investigator and experimental
      apparatus. The participant will be instructed to "relax and breathe" through a facemask
      connected to a non-rebreathing valve in line with a differential pressure transducer. The
      inspiratory port of the valve will be connected to the resistive loading manifold. The
      manifold consists of 5 differential resistors ranging from 5 - 40 centimeters/water (cmH2O)
      of resistive pressure, separated by stoppered ports, as well as a no load condition. The load
      is applied by removing the stop for an entire inspiratory breath, and then replacing the port
      to continue resting tidal breathing. The pressure transducer will provide measures of mouth
      pressure and airflow, which will be digitized and recorded to a desk top computer using
      LabChart software. Following each loaded breath, the participant will provide an estimate of
      the perceived difficulty of breathing using a modified Borg scale.

      Participants will be familiarized with the loads in a practice session prior to initiating
      the experimental protocol. During the experimental session, participants will listen to music
      of their choice in order to mask experimental sounds. The resistive loads will be applied in
      a randomized block design, with each loaded breath separated by at least three unloaded
      breaths. Two blocks will be completed with each load presented between 3 and 5 times within
      each block. Therefore, there will be a total of between 15 and 25 loaded breaths (3-5 loads x
      5 presentations) per block. Participants will be instructed that when they see a small light
      flash briefly on the table in front of them (which they will be familiarized with prior to
      beginning the experiment) a resistive load will be applied to the next breath. Following the
      loaded breath, the participant will be asked to estimate the perceived difficulty of
      breathing on the Borg scale.

      Rehabilitation barium swallow study: Participants with PD who are referred for a
      rehabilitation barium swallowing evaluation will be recruited for this study. Therefore, the
      swallowing evaluation is part of the normal clinical care of the patients and may vary based
      on the clinical necessity as judged by the treating speech-language pathologist. 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. 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 (ranging from 1-8, where 1 is no
      penetration or aspiration, and 8 is silent aspiration). The PA score will be recorded in
      order to determine whether the participant has trouble swallowing (scores of 3-8) or not
      (scores of 1 and 2).
observational model: Case-Control
time perspective: Prospective
measure: Perceived difficulty inhaling against each respiratory resistive load.
time frame: Baseline
description: 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.'
measure: The amount of pressure generated while inhaling against each resistive load
time frame: Baseline
description: 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
measure: Total amount of air that can be expired from the lungs
time frame: Baseline
description: Spirometry will be used to determine the forced vital capacity, and forced expiratory volume in 1 second.
measure: The maximum amount of inspiratory pressure
time frame: Baseline
description: A manometer will be used to measure the maximum inspiratory pressure each participant can generate.
measure: Feelings of sadness or depression
time frame: Baseline
description: 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).
measure: Feeling apathetic, or indifferent.
time frame: Baseline
description: 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.
measure: Ability to swallow liquids and solids without material entering the airway
time frame: Baseline
description: 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).
arm group label: Parkinson's disease
description: 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.
arm group label: Healthy adults
description: Men and women without Parkinson's disease, between 45 and 85 years of age. The following will be done: Respiratory resistive load on inhalation.
intervention type: Other
intervention name: Respiratory resistive load on inhalation
description: 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.
arm group label: Healthy adults
arm group label: Parkinson's disease
intervention type: Other
intervention name: Fluoroscopic swallowing evaluation
description: 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.
arm group label: Parkinson's disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karen W Hegland, PHD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease