Parkinson's DiseaseNCT02202057
Respiratory Load Magnitude Estimation in PD
An observational study of Parkinson's Disease and Aging, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Aging
- What is being tested?
- Respiratory resistive load on inhalation and Fluoroscopic swallowing evaluation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32611
About this study
Official title: Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease
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.
Read the detailed description
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).
- Conditions
- Parkinson's Disease, Aging
- Being tested
- Respiratory resistive load on inhalation, Fluoroscopic swallowing evaluation
- Keywords
- respiratory sensation, somatosensation, resistive load, magnitude estimation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory resistive load on inhalationOther
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.
Fluoroscopic swallowing evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Respiratory resistive load on inhalation; Other: Fluoroscopic swallowing evaluation | |
| 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. Receives: Other: Respiratory resistive load on inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived difficulty inhaling against each respiratory resistive load.
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.'
Measured: Baseline
Secondary outcomes (1)
The amount of pressure generated while inhaling against each resistive load
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen W Hegland, PHD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202057
- Sponsor's protocol ID
- IRB201400183
- Status last verified
- Sep 2016
- First submitted
- 24 Jul 2014
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnitude Estimation of Respiratory Resistive Load in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02202057
- Acronym / sponsor ID
- IRB201400183
- Conditions
- Parkinson's Disease, Aging
- Keywords
- respiratory sensation, somatosensation, resistive load, magnitude estimation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Other: Respiratory resistive load on inhalation, Other: Fluoroscopic swallowing evaluationMen 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. |
| Healthy adults | – | Other: Respiratory resistive load on inhalationMen and women without Parkinson's disease, between 45 and 85 years of age. The following will be done: Respiratory resistive load on inhalation. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory resistive load on inhalationThe 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 | Healthy adults, Parkinson's disease |
| Fluoroscopic swallowing evaluationParticipants 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. | Other | Parkinson's disease |
Primary outcome
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.'
1 secondary outcome
The amount of pressure generated while inhaling against each resistive load
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen W Hegland, PHD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived difficulty inhaling against each respiratory resistive load. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.