Home Apnea Testing in CHildren Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorChildren's Hospital of Philadelphia
About this trial
This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.
Eligibility criteria
Qualifiers
Male and female children age 5-12 years old inclusive
Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
Parental/guardian permission (informed consent) and if appropriate, child assent.
Disqualifiers
Children without Down syndrome who have had a PSG within 3 years of enrollment
Children with Down syndrome who have had a PSG within 1 year of enrollment.
Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
Children with a tracheostomy or tracheocutaneous fistula
Trial design
Treatments tested in this trial
- Home sleep apnea test
- In-lab polysomnography
Treatment groups
317 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Miami
Collaborator
Source ClinicalTrials.gov