- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090671
Evaluation of the Multidimensional Dyspnea Profile (MDP)
Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study sites will examine patients with COPD (Chronic obstructive pulmonary disease) in state of acute exacerbation and in stable state, patients with congestive heart failure (CHF) in state of acute decompensated cardiac insufficiency, and patients newly diagnosed with obstructive sleep apnea (OSA) as a control group.
In the acute setting of COPD and CHF, the questionnaire will be given at the day of hospital admission and at the day of discharge. The patients will additionally fill the Severe Respiratory Insufficiency (SRI) Questionnaire (in COPD) or the Physical Activity Questionnaire 50+ (in CHF).
In stable state of COPD, the questionnaires will be given once during a routine control visit at the hospital or the medical practice.
In OSA, the questionnaire will be given once during the first visit in the sleep laboratory.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Georg Nilius, Prof.Dr.med
- Phone Number: 22000 0049 (0) 201 174
- Email: g.nilius@kem-med.com
Study Contact Backup
- Name: Ulrike Domanski
- Phone Number: 2080 0049 (0) 2331 974
- Email: ulrike.domanski@helios-gesundheit.de
Study Locations
-
-
NRW
-
Essen, NRW, Germany, 45276
- Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
-
Hagen, NRW, Germany, 58091
- Helios Klinik Hagen Ambrock
-
Lüdenscheid, NRW, Germany, 58515
- Märkische Kliniken GmbH, Klinikum Lüdenscheid
-
Menden, NRW, Germany, 58706
- Praxis Dr. med V. Jansen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- COPD patients with acute exacerbation (Group I)
- CHF patients with acute decompensation (group II)
- stable COPD patients (group III)
- OSA patients with AHI>15 (group IV)
Exclusion Criteria:
- Other severe acute diseases that contradict the participation in a clinical trial
- Simultaneous participation in another clinical trial
- Not capable of giving consent
- Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: COPD Exacerbation
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
|
The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts.
It tests five sensory qualities that describe the patient's dyspnea in its respective intensity.
Additionally it includes five potential reactions.
The MDP is designed to refer to a specific event of time.
Other Names:
|
Active Comparator: CHF
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
|
The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts.
It tests five sensory qualities that describe the patient's dyspnea in its respective intensity.
Additionally it includes five potential reactions.
The MDP is designed to refer to a specific event of time.
Other Names:
|
Active Comparator: COPD
In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice.
|
The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts.
It tests five sensory qualities that describe the patient's dyspnea in its respective intensity.
Additionally it includes five potential reactions.
The MDP is designed to refer to a specific event of time.
Other Names:
|
Active Comparator: OSA
The questionnaire MDP will be administered once during the first visit in the sleep laboratory.
|
The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts.
It tests five sensory qualities that describe the patient's dyspnea in its respective intensity.
Additionally it includes five potential reactions.
The MDP is designed to refer to a specific event of time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MDP scores during hospital stay
Time Frame: day 1 to day 5
|
A1, Scale: Scale about breathing sensations with a defined start- and endpoint (neutral - unbearable). Values reach from 0-10, and higher values represent a worse outcome. SQ1 (sensoric quality), Choice: 5 Phrases and terms about breathing sensations. Choose between yes and no and select one as "most accurately". SQ2 (sensoric quality), Scales: 5 subscales about intensity of breathing sensations (muscle work; air hunger; chest tightness; mental effort; breathing a lot) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome. A2 (emotional quality), Scales: 5 subscales about emotions (depressed, anxious, frustrated, angry, afraid) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome. |
day 1 to day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of MDP scores with clinical data
Time Frame: 1 to 5 (+- 3) days
|
comparison of the A1 and A2 (scale 0-10) and SQ2 (scale 0-10) scores of the MDP between the diseases, the evaluation of dependencies of clinical routine data with the MDP scores
|
1 to 5 (+- 3) days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Georg Nilius, Prof.Dr.med, KEM Kliniken Essen-Mitte
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDP2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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