Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders

Completed

• Conditions: Airway Obstruction

• Registration Number: NCT03054116
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

In a prospective, observational study the investigators compared resistance values measured using the airway perturbation device (APD) to impulse oscillometry and spirometry. The investigators also created reference equations for normal APD resistance ranges using the data from clinically normal volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-01
• Primary Completion: 2014-08-31
• Study Completion: 2014-08-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-15
• Last Update Submitted: 2017-02-19
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Male and female subjects > 18 years
• Referred for PFTs and/or PSG at WRNMMC
• All races and ethnicities will be included
• Pregnant women will be included

Exclusion Criteria

• < 18 years of age
• If mental status is questionable, the patient will be excluded at the discretion of the consenting provider
• Unable/unwilling to follow the directions necessary for APD use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with APD correlation > 0.5 with spirometry	At enrollment	Respiratory resistance ( cm H20/L/s) measured with APD correlated with volumes (in liters) measured by spirometry.

Secondary Outcome Measures

Name	Time	Method
Number of participants with APD correlation > 0.5 with impulse oscillometry	At enrollment	Respiratory resistance (cm H20/L/s) measured with APD correlated with resistance (cm H20/L/s) measured using impulse oscillometry