NCT05911646 · Connecticut Children's Medical Center
OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
(OSA-18)
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
OSA-18 Survey
OSA 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.
OTHER
Decisional Conflict (DCS)
The 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.
Primary outcome measures
Decisional Conflict Scale (DCS)
Time frame: Through clinical visit, an average of 30 minutes
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Hartford, Connecticut
Collaborators
ResMed Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations