Airway ObstructionNCT03054116
Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders
An observational study of Airway Obstruction, run by Walter Reed National Military Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Airflow pertubation device
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 31 Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to the Walter Reed NNMC pulmonary clinic mixed with clinically normal volunteers.
Who may be able to join
- 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
Who cannot join
- < 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
About this study
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.
- Conditions
- Airway Obstruction
- Being tested
- Airflow pertubation device
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airflow pertubation deviceDiagnostic test
Also called APD
Participants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (1)
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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Apr 2013
- Primary completion31 Aug 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Aaron B. Holley, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054116
- Sponsor's protocol ID
- 383145
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders
- ClinicalTrials.gov ID
- NCT03054116
- Acronym / sponsor ID
- 383145
- Conditions
- Airway Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Walter Reed NNMC pulmonary clinic mixed with clinically normal volunteers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airflow pertubation deviceAlso: APDParticipants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Number of participants with APD correlation > 0.5 with impulse oscillometry
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction, run by Walter Reed National Military Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with APD correlation > 0.5 with spirometry (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.