OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorConnecticut Children's Medical Center
About this trial
The concept is a novel research idea that incorporates the potential impact of patient quality of life (QOL) on decision-making for treatment of mild obstructive sleep apnea (OSA). Our hypothesis is that in children with mild OSA there is significant conflict with parental decision-making; in the absence of significant sleep apnea, there is limited research regarding comparative efficacy of various treatment options. The impact of a QOL questionnaire can be a significant deciding factor and may help guide management decisions in such situations.
Eligibility criteria
Qualifiers
Parent/caregiver of child with an initial diagnosis mild obstructive sleep apnea defined as polysomnography AHI score between 1 and 5
Parent/caregiver of child between 3 and 12 years of age
Parent/caregiver of child who has been diagnosed with tonsillar hypertrophy grade 2 or higher
Disqualifiers
Parent/caregiver of child diagnosed with a syndromic or known neurologic condition and/or multiple (more than two) medical cardiac or respiratory medical conditions
Parent/caregiver of child who has previously underwent tonsillectomy
Trial design
Treatments tested in this trial
- OSA-18 Survey
- Decisional Conflict (DCS)
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Connecticut Children's Medical Center
Lead sponsor
ResMed Foundation
Collaborator
Source ClinicalTrials.gov