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

February 19, 2017 updated by: Aaron B. Holley, Walter Reed National Military Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to the Walter Reed NNMC pulmonary clinic mixed with clinically normal volunteers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with APD correlation > 0.5 with impulse oscillometry
Time Frame: At enrollment
Respiratory resistance (cm H20/L/s) measured with APD correlated with resistance (cm H20/L/s) measured using impulse oscillometry
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

August 31, 2014

Study Completion (Actual)

August 31, 2014

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 383145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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