Status:

RECRUITING

Feasibility of Cough Monitoring in Children

Lead Sponsor:

University of Colorado, Denver

Conditions:

Cystic Fibrosis in Children

Eligibility:

All Genders

1-18 years

Brief Summary

Cystic fibrosis (CF) is a disease characterized by chronic airway infection and impaired mucociliary clearance, which predisposes those affected to recurrent pulmonary exacerbations (PEx) and progress...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Children with Cystic Fibrosis
  • Diagnosis of CF based on 2 known CFTR mutations and/or sweat chloride \> 60 mmol/L
  • Ages 1-18 years of age
  • Clinically stable at the time of consent
  • Exclusion Criteria
  • Use of nocturnal positive pressure or supplemental oxygen
  • Shared bedroom with sibling
  • Use of oral or IV antibiotics within the past 2 weeks except for chronic azithromycin use
  • Shared custody (i.e., the participant is splitting time between time households)
  • Inclusion Criteria for Healthy Controls
  • Ages 1-18
  • Exclusion Criteria:
  • Shared bedroom with sibling
  • Underlying chronic respiratory or cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease or other condition felt by the investigator to cause chronic nighttime symptoms
  • Shared custody (i.e., the participant is splitting time between time households)

Exclusion

    Key Trial Info

    Start Date :

    February 27 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2024

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT06587126

    Start Date

    February 27 2024

    End Date

    December 1 2024

    Last Update

    September 19 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Children's Hospital of Colorado

    Aurora, Colorado, United States, 80045