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

NCT ID: NCT03054116

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-01

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Airflow pertubation device

Participants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

APD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Walter Reed National Military Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aaron B. Holley

Aaron Holley, MD, Chief of Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

383145

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.