Utility of PCD Diagnostics to Improve Clinical Care

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT05889013
Status
Recruiting
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Conditions

  • Primary Ciliary Dyskinesia

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nasal Nitric Oxide testing — DEVICE
    Collection of already performed clinical data and nNO testing

Study Details

This cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). There is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. Individuals with PCD characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. The objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (PCD).

Key Dates

Start date
Oct 17, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Nasal Nitric Oxide
    Participants who are referred by his/her clinician for nasal NO testing and meet the inclusion and exclusion criteria will undergo testing. Clinical information regarding prior diagnostic testing will be collected at time of enrollment. Participants that have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry

Primary Outcome Measure

Creation of Nasal NO REDCap registry [ Time Frame: 2-3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pulmonary DivisionHartfordConnecticut06111
Melanie S Collins, MD
[email protected]
8605459440
Sigrid M Almeida, BS
[email protected]
8608375343

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By research site
Pulmonary Division· Hartford, CT

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