Recruiting

OSA-18

Sponsor:

Connecticut Children's Medical Center

Code:

NCT05911646

Conditions

Apnea, Obstructive Sleep

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

Interventions

OSA-18 Survey

Decisional Conflict (DCS)

Study Details

Brief 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.

Conditions

Apnea, Obstructive Sleep

Obstructive Sleep Apnea

Study ID

NCT05911646

Start date

Jun 2, 2021

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: OSA-18 Case Group

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.

active comparator: Control Group

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.

Interventions

OSA-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.

Decisional 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.

Primary outcome measure

  • Decisional Conflict Scale (DCS) [ Time Frame: Through clinical visit, an average of 30 minutes ]

Central Contacts and Locations

Central contacts

Nancy Grover, MD

860- 545- 9650ngrover@connecticutchildrens.org

Cameron King, MA

8608375595CKing02@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Nancy Grover, MD

ngrover@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Mild Obstructive Sleep Apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-05-28.