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

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054116
• Other study ID #: 383145
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 19, 2017
• Start date: April 1, 2013
• Est. completion date: August 31, 2014

Study information

• Verified date: February 2017
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: August 31, 2014
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Parasomnias
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Airflow pertubation device
Participants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with APD correlation > 0.5 with spirometry	Respiratory resistance ( cm H20/L/s) measured with APD correlated with volumes (in liters) measured by spirometry.	At enrollment
Secondary	Number of participants with APD correlation > 0.5 with impulse oscillometry	Respiratory resistance (cm H20/L/s) measured with APD correlated with resistance (cm H20/L/s) measured using impulse oscillometry	At enrollment