Sham CPAP vs. Straight CPAP for Chronic Cough

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-13

Study Completion Date

2019-11-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Cough OSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Straight CPAP

Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.

Group Type EXPERIMENTAL

Straight CPAP

Intervention Type DEVICE

Sham CPAP

Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks.

Group Type SHAM_COMPARATOR

Sham CPAP

Intervention Type DEVICE

Interventions

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Straight CPAP

Intervention Type DEVICE

Sham CPAP

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No