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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment for mild obstructive sleep apnea?

Research shows that using decision aids, like videos, can help people make better choices about their sleep apnea treatments, reducing their uncertainty and improving their readiness to decide. This suggests that tools addressing decisional conflict can be effective in helping patients with mild obstructive sleep apnea choose the right treatment. ^{1 2 3 4 5}

How does the OSA-18 Survey treatment for mild obstructive sleep apnea differ from other treatments?

The OSA-18 Survey treatment is unique because it focuses on assessing the quality of life and symptoms in children with mild obstructive sleep apnea, rather than directly treating the condition. This approach helps in understanding the impact of the condition on daily life, which can guide further treatment decisions. ^{1 2 3 4 6}

Research Team

Nancy Grover, MD

Principal Investigator

Connecticut Children's Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Video-Based Decision Aids Improve Sleep Surgery Decision-Making: A Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Characterizing Decisional Conflict in Patients Presenting to Sleep Surgery Clinic and an Exploration of Resource Limitations. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Characterizing Decisional Conflict for Caregivers of Children With Obstructive Sleep Apnea Without Tonsillar Hypertrophy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Validation of CollaboRATE and SURE - two short questionnaires to measure shared decision making during CPAP initiation. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Development of a Decision Aid for Parents Who Elect Tonsillectomy for Obstructive Sleep Apnea. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

Clinical and Polysomnographic Correlates of Subjective Sleepiness in Mild Obstructive Sleep Apnea. [2022]