Using a quality of life tool to help parents decide on treatment for children with mild sleep apnea
OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
NA · Connecticut Children's Medical Center · NCT05911646
This study is testing whether a quality of life questionnaire can help parents make better treatment choices for their children aged 3 to 12 with mild sleep apnea.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center (other) |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT05911646 on ClinicalTrials.gov |
What this trial studies
This study explores how a quality of life (QOL) questionnaire can assist parents in making treatment decisions for children aged 3 to 12 with mild obstructive sleep apnea (OSA). The research aims to address the decisional conflict parents face when choosing between treatment options such as watchful waiting, surgery, or medical therapy. By incorporating the OSA-18 survey and assessing decisional conflict, the study seeks to provide caregivers with valuable insights that may lead to more informed management choices. The goal is to improve the decision-making process and potentially enhance the quality of life for affected children.
Who should consider this trial
Good fit: Ideal candidates include parents or caregivers of children aged 3 to 12 diagnosed with mild obstructive sleep apnea and tonsillar hypertrophy grade 2 or higher.
Not a fit: Patients who have syndromic or known neurologic conditions, or those who have previously undergone tonsillectomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower parents with better decision-making tools, leading to improved treatment outcomes for children with mild obstructive sleep apnea.
How similar studies have performed: While the approach of using quality of life assessments in decision-making is relatively novel, previous studies have indicated that parental decisional conflict is significant in similar contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hartford, Connecticut
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Nancy Grover, MD — Connecticut Children's Medical Center
- Study coordinator: Nancy Grover, MD
- Email: ngrover@connecticutchildrens.org
- Phone: 860- 545- 9650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Apnea, Obstructive Sleep, Obstructive Sleep Apnea, Mild Obstructive Sleep Apnea