RecruitingNot ApplicableNCT05911646

OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?


Sponsor

Connecticut Children's Medical Center

Enrollment

130 participants

Start Date

Jun 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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

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Interventions

OTHEROSA-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.

OTHERDecisional 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.


Locations(1)

Connecticut Children's Medical Center

Hartford, Connecticut, United States

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NCT05911646


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