OSA Clinical Trial
Official title:
Prospective Study of Efficacy of Sham CPAP vs. Straight CPAP on Cough Intensity in Patients With Chronic Cough
Verified date | June 2020 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic cough is an important clinical problem in primary care and sub-specialty practice.
Besides the distress experienced by patients with chronic cough, significant healthcare
resources are expended to understand the role of gastroesophageal reflux, asthma and
post-nasal drip in understanding their contribution to cough.
Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly,
treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in
cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough
includes beneficial effects on reflux and airway inflammation.
The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in
chronic cough patients improves cough. While these patients with chronic cough are not
routinely screened and treated for OSA, this study aims to evaluate these chronic cough
patients with screening questionnaires for OSA and if necessary with polysomnography and
randomize them to either CPAP or sham CPAP for 6 weeks.
Status | Completed |
Enrollment | 22 |
Est. completion date | November 25, 2019 |
Est. primary completion date | November 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Cough of more than 2 month duration - Not active smoker with history of stoppage of smoking for more than 6 months - Evaluation and treatment by other providers for suspected gastroesophageal reflux disease (GERD), upper airway cough syndrome (UACS), or cough-variant asthma (CVA) for at least 1 month - Normal chest radiography or computed tomography (CT) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere) - Normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (DLCO) more than 50% predicted. Pulmonary Function Test criteria: no evidence of airflow limitation (FEV1/FVC > 0.7) or significant chest restriction (FVC > 70% predicted) with predicted DLCO more than 50% predicted Exclusion Criteria: - Pregnancy - Recent pneumonia (less than 6 months) - Congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy - Use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded) - Use of opiates for cough suppression (opiate use for pain suppression can be included) - Alcoholism, drug dependence (including chewing tobacco) or illicit drug use - Esophageal cancer or laryngeal surgery - Craniofacial abnormalities that preclude CPAP placement |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Krishna M. Sundar |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Leicester Cough Questionnaire Score | Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks | |
Secondary | Change in Cough Frequency | Subjects will wear a Leicester cough monitor for 24 hours at the baseline and 6-week visits, which will record cough frequency during that period. The change in cough frequency from baseline to 6 weeks will be compared between the Straight CPAP and SHAM CPAP groups | Baseline and 6 weeks | |
Secondary | 8 Isoprostane Level in Exhaled Breath Condensate | Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The 8 isoprostane level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks | |
Secondary | Interleukin-8 (IL-8) Level in Exhaled Breath Condensate | Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. IL-6 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks | |
Secondary | Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate | Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. NOX level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups. | Baseline and 6 weeks | |
Secondary | Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate | Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. H2O2 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks | |
Secondary | Change in Leukotriene B4 (LTB4) Level in Exhaled Breath Condensate | Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The change in LTB4 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks | |
Secondary | Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score | Subjects will complete the GERD-QoL questionnaire at the baseline and 6-week visits. The GERD-QoL comprises 15 items on a five-point Likert scale; lowest possible score (0) = no symptoms, greatest possible score (75) = worst symptoms. The change in GERD-QoL score will be compared between the Straight CPAP and Sham CPAP groups | Baseline and 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05404438 -
Mouth Breathing Habits Improvement Intervention
|
N/A | |
Recruiting |
NCT05960175 -
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
|
N/A | |
Recruiting |
NCT05813275 -
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
|
Phase 3 | |
Completed |
NCT05075668 -
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
|
N/A | |
Completed |
NCT05881512 -
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT03336515 -
Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
|
N/A | |
Not yet recruiting |
NCT05944965 -
Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea
|
Phase 1/Phase 2 | |
Completed |
NCT02387476 -
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
|
N/A | |
Not yet recruiting |
NCT06058052 -
Prevalence of OSA in Patients of ILD
|
||
Recruiting |
NCT03721445 -
Could HRV be a Valuable Predictor for CPAP Adherence?
|
||
Recruiting |
NCT06320795 -
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
|
N/A | |
Completed |
NCT01717339 -
Sleep Apnea and Vascular Function
|
N/A | |
Completed |
NCT00772044 -
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
|
Phase 4 | |
Recruiting |
NCT06400615 -
Study That Tests AD109 in Patients Taking GLP-1 Drugs
|
Phase 2 | |
Completed |
NCT02438137 -
Dimethyl Fumarate for Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT01672606 -
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
|
N/A | |
Not yet recruiting |
NCT06110962 -
Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
|
||
Completed |
NCT05060133 -
Changes of the Upper Airway Volume After Orthognathic Surgery
|
||
Completed |
NCT03196583 -
Efficacy of a Novel MAD in OSA
|
N/A | |
Not yet recruiting |
NCT03933046 -
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
|
N/A |