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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OSA-18 Survey
Other interventionOSA 18 is an 18-item questionnaire that uses a Likert-type scoring system to collect information about 5 subscales that are considered to be elements in quality of life: sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. On the basis of this information, a summary score is calculated and scores are divided into three categories: Mild (40-60), moderate (61-80) and severe \>81.
Decisional Conflict (DCS)
Other interventionThe DCS is a 16-item survey in which participants are asked to respond to statements related to their decision on a five-point ordinal Likert scale: 0) strongly agree, 1) agree, 2) neither agree nor disagree, 3) disagree, and 4) strongly disagree. Scores are summed, divided by 16, and multiplied by 25. Scores range from 0, signifying that the respondent has complete certainty about the best choice, to 100, which signifies that the respondent feels extremely uncertain about the best choice.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: OSA-18 Case GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale (DCS) is a survey administered to both the experimental and active comparator evaluating the degree of conflict a caregiver feels when determining a treatment option. The minimum score is 0 (indicating no decisional conflict) and the maximum score is 100 (indicating significant decisional conflict).
Time frame
Through clinical visit, an average of 30 minutesSecondary outcomes
1
Gender of child and parent/legal guardian
* Male * Female * Intersex * None of these describe my child * Prefer not to answer
Time frame
Through clinical visit, an average of 30 minutes2
Age of child and parent/legal guardian
years
Time frame
Through clinical visit, an average of 30 minutes3
Race/Ethnicity of child and parent/legal guardian
* American Indian or Alaska Native * Asian * Black or African American * Hispanic or Latino * Native Hawaiian or Other Pacific Islander * White * Prefer not to answer
Time frame
Through clinical visit, an average of 30 minutes4
Parent/legal guardian identified health care literacy and comfort completing medical forms.
* Extremely * Quite a bit * Somewhat * A little bit * Not at all
Time frame
Through clinical visit, an average of 30 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Connecticut Children's Medical Center
Lead sponsor
ResMed Foundation
Collaborator
Source ClinicalTrials.gov