130 Participants Needed

OSA-18 Survey for Mild Obstructive Sleep Apnea

(OSA-18 Trial)

NG
MA
CK
Overseen ByCameron King, MA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Connecticut Children's Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12346

Who Is on the Research Team?

NG

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: OSA-18 Case GroupExperimental Treatment2 Interventions
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

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

Video-Based Decision Aids Improve Sleep Surgery Decision-Making: A Randomized Controlled Trial. [2023]
Characterizing Decisional Conflict in Patients Presenting to Sleep Surgery Clinic and an Exploration of Resource Limitations. [2021]
Characterizing Decisional Conflict for Caregivers of Children With Obstructive Sleep Apnea Without Tonsillar Hypertrophy. [2019]
Validation of CollaboRATE and SURE - two short questionnaires to measure shared decision making during CPAP initiation. [2020]
Development of a Decision Aid for Parents Who Elect Tonsillectomy for Obstructive Sleep Apnea. [2022]
Clinical and Polysomnographic Correlates of Subjective Sleepiness in Mild Obstructive Sleep Apnea. [2022]
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