Cystic Fibrosis Clinical Trial
— HFCWOOfficial title:
Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
Verified date | December 2018 |
Source | Hill-Rom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will be an open label laboratory study with all subjects receiving HFCWO with The
Monarch® System
Objective:
Assess device settings and to identify frequency/pressure (intensity) combinations that
produce high airflow and oscillating volume
Methodology:
Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity
combinations on a single visit day. Frequency / intensity combinations will be evaluated to
determine which settings produce highest airflow and highest oscillating volume.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | April 12, 2019 |
Est. primary completion date | March 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Documented diagnosis of CF (by sweat test and/or genetics - Age > 15 years - Require regular home airway clearance therapy - Current user of The Monarch® System with a minimum of 4 weeks experience with the device - Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent - Patient must be on a stable regimen of CF medication Exclusion Criteria: - History of pneumothorax within the past 6 months prior to study visit - History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days - History of lobectomy - Recent chest surgery or chest trauma - Inability to perform The Monarch® System therapy as directed - Pregnant or lactating female - Have a pacemaker or implantable cardioverter defibrillator (ICD) - Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hill-Rom |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak oscillating expiratory airflow measurements | Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing |
4-6 hours | |
Secondary | Oscillating volume | Oscillating volume measurement will be conducted concurrently with the measurement of flow. Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings as described above. Data from the measurement of oscillating volume for each frequency/intensity combination setting will be processed following the completion of the testing |
4-6 hours | |
Secondary | Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS) | Following the completion of testing for each frequency/intensity combination setting, subjects will rate the level of comfort/discomfort of the setting on a VAS. A Visual Analogue Scale is a psychometric response scale which will be used as a measuring instrument for subjective comfort or discomfort. It is a measurement instrument that ranges across a continuum of values and used to measure the intensity or frequency of various symptoms. The Visual Analogue Scale ranges from (0 to 100 mm). Zero means very uncomfortable/intolerable and 100 means very comfortable. The subject will mark the line for each setting combination to indicate the level of comfort or discomfort. After the Study visit, the research staff will measure the mark on the line and document the value. |
4-6 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |