OSA-18 Survey for Mild Obstructive Sleep Apnea

(OSA-18 Trial)

Overseen By Cameron King, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Disqualifiers: Syndromic, Neurologic, Cardiac, Respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a quality of life questionnaire can assist parents in making better treatment decisions for children with mild obstructive sleep apnea (OSA). The study will compare two groups: one using the OSA-18 survey (a quality of life questionnaire) to guide discussions and the other using a standard informational aid. It examines how these tools influence parents' decision-making and their sense of conflict when choosing treatments. The trial is suitable for parents of children aged 3 to 12 with mild OSA and enlarged tonsils. As an unphased trial, this study provides parents with a unique opportunity to contribute to research that may enhance decision-making tools for future families.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the OSA-18 Survey is safe for assessing quality of life in children with mild obstructive sleep apnea?

Research shows that the OSA-18 survey measures the quality of life in children with obstructive sleep apnea (OSA). This survey consists of questions that reveal how OSA impacts a child's daily life. The OSA-18 survey is safe, involving only questions without any medication or physical treatment.

Participants answer questions about sleep, physical symptoms, emotions, daytime activities, and caregiver concerns. Many studies have used the survey to understand OSA's impact on children. As a questionnaire, it has no reported negative effects or side effects. It provides a simple, non-invasive way to gather important information about how OSA affects a child's quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing mild obstructive sleep apnea (OSA) by focusing on patient and family decision-making. Unlike traditional treatments that primarily focus on medical interventions like CPAP machines or lifestyle changes, this trial uses the OSA-18 survey to assess the impact of sleep apnea on quality of life, providing families with a clearer picture of how the condition affects daily living. This personalized insight, combined with a decisional aid, helps guide families through treatment options, potentially leading to more informed and confident decisions. By prioritizing the patient's quality of life and the family's involvement in the treatment process, this trial aims to enhance the overall management of mild OSA.

What evidence suggests that this trial's treatments could be effective for mild obstructive sleep apnea?

Research has shown that the OSA-18 survey assesses the quality of life in children with mild obstructive sleep apnea (OSA). In this trial, the OSA-18 Case Group will receive the survey to understand how OSA affects children's daily lives and guide treatment decisions. The survey covers sleep problems, physical symptoms, emotional well-being, daytime activities, and caregiver concerns. However, studies indicate that the OSA-18 survey might not always accurately predict which children will develop more severe OSA. Despite this limitation, it can still assist families in choosing the best treatment by highlighting how OSA impacts their child's life. ^{1 2 6 7 8}

Who Is on the Research Team?

Nancy Grover, MD

Principal Investigator

Connecticut Children's Medical Center

Are You a Good Fit for This Trial?

This trial is for parents or caregivers of children aged 3-12 with mild obstructive sleep apnea (OSA), characterized by an AHI score of 1-5 and tonsillar hypertrophy grade 2 or higher. It's not suitable for those caring for children with syndromic/neurologic conditions, multiple medical issues, or previous tonsillectomy.

Inclusion Criteria

I am a parent or caregiver of a child aged 3 to 12.

My child has mild sleep apnea with an AHI score between 1 and 5.

My child has been diagnosed with significant tonsil enlargement.

Exclusion Criteria

I am the caregiver of a child with a neurological condition or multiple heart or lung issues.

My child has had their tonsils removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Recruitment and Consent

Participants are recruited and consent is obtained for participation in the trial

1 week

1 visit (in-person or virtual)

Consultation and Intervention

Participants undergo consultation where they receive a decision aid and complete the OSA-18 questionnaire if in the case group

1 day

1 visit (in-person)

Follow-up

Participants complete the Decisional Conflict Scale survey to assess decision-making conflict

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Decisional Conflict (DCS)
• OSA-18 Survey

Trial Overview The study tests if the OSA-18 Survey, a quality of life questionnaire, can help parents make treatment decisions for their child's mild OSA. The survey aims to reduce decisional conflict by providing insights into how OSA affects the child’s daily life.

How Is the Trial Designed?

Group I: OSA-18 Case Group Experimental Treatment 2 Interventions

Case group participants will be given the OSA-18 survey at the start of their consultation. OSA-18 is an 18-item questionnaire that collects 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. The score is calculated that ranges from 18 (no impact on quality of life) to 126 (major negative impact). Upon completion of OSA-18, scores are tabulated and relayed to families through a decisional aid. The score and the aid, which explains treatment options, risks and benefits will be used to guide discussion throughout the consultation. After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey. All surveys will remain anonymous by using a unique study identifier. Forms will be placed in a locked box by parents prior to departure from the exam room.

Group II: Control Group Active Control 1 Intervention

During the consultation, families will be given a printed form, "decisional aid," which is given to families to explain treatment options as well as their risks and benefits. The consultation will proceed as normal according to standard of care with the aid being used to guide conversation. After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey to complete. All surveys will remain anonymous and only a unique study identification number will be placed on the surveys to correctly match each survey. Forms will be placed in a locked box by parents prior to departure from the exam room.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

ResMed Foundation

Collaborator

Trials

15

Recruited

1,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9895508/

OSA 18 Questionnaire: Tool to Evaluate Quality of Life and ... OSA-18 questionnaire is self-administered and disease specific screening tool for early diagnosis and evaluation of QOL before and after treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7954089/

Polysomnographic Outcomes After Observation for Mild ... Mild obstructive sleep apnea (OSA), particularly in young children, is often treated with observation. However, there is little evidence regarding the outcomes ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079220300988

Diagnostic meta-analysis of the Pediatric Sleep ... Questionnaire OSA-18 has poor validity compared to polysomnography in pediatric obstructive sleep apnea ... Consequences of Obstructive Sleep Apnea in Children.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05911646/osa-18-in-children-with-mild-obstructive-sleep-apnea-can-it-be-a-helpful-decision-making-tool?page=3&state=CT&city=Hartford

OSA-18 in Children With Mild Obstructive Sleep Apnea Our hypothesis is that in children with mild OSA there is significant conflict with parental decision-making; in the absence of significant ...

5. publications.aap.org publications.aap.org/pediatrics/article/125/1/e162/29714/Can-the-OSA-18-Quality-of-Life-Questionnaire

Can the OSA-18 Quality-of-Life Questionnaire Detect ... The OSA-18 does not accurately detect which children will have an abnormal MOS and cannot be used to exclude moderate-to-severe OSA.

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812479

Adenotonsillectomy for Snoring and Mild Sleep Apnea in ... An independent data and safety monitoring board reviewed interim data on safety and study quality. An independent medical monitor ...

7. turkarchotolaryngol.net turkarchotolaryngol.net/articles/optimizing-early-detection-validating-obstructive-sleep-apnea-18-osa-18-in-turkish-speaking-pediatric-patients/tao.2023.2023-10-1

Validating Obstructive Sleep Apnea-18 (OSA-18) in Turkish ... This study's objective is to culturally adapt and validate the Turkish version of the OSA-18 questionnaire, a commonly used tool for assessing QoL in children ...

8. journals.lww.com journals.lww.com/prcm/fulltext/2019/03030/usefulness_of_obstructive_sleep_apnea_18_as_a.4.aspx

Usefulness of Obstructive Sleep Apnea-18 as a Predictor of... The aim of this study is to determine whether the OSA-18 quality of life (QoL) questionnaire could predict moderate-to-severe OSA in children with normal/ ...