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

May 26, 2026 updated by: Nancy Grover, Connecticut Children's Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This concept is a novel research idea that incorporates the potential impact of patient quality of life (QOL) on decision making for treatment of mild sleep apnea in children between the ages of 3yrs to <16 years. Previous studies have shown that parents of children with mild OSA experience similar decisional conflict (DC) to those with a more severe disease. The investigators believe it is important to provide caregivers with tools that can aid in decision making and potentially reduce DC when choosing between more than one treatment option, considering research on some of these options is also recent and somewhat limited.

Children with mild OSA may be offered watchful waiting, surgery or medical therapy for initial management. Although surgery results in resolution/improvement in symptoms in the majority of children with mild OSA, recent data also shows encouraging success rates after medical management. A well-designed RCT has also shown that untreated children with non-severe OSA show normalization of PSG with watchful waiting, although they continued to have higher OSA18 scores as compared to those who underwent surgery. This implies that there is a continuing impact on quality of life and warrants inclusion of this information early on in the decision-making process.

When presented with these data, some parents face a conflict deciding between management options and/or may be reluctant to pursue the recommended management option. This is known as "decisional conflict" and is frequently accompanied by emotional distress, which can lead to delays in decision making.

The hypothesis is that in children with mild OSA there is significant conflict in parental decision making, and, in the absence of significant sleep apnea, impact on QOL can be a statistically significant deciding factor and may help guide management decisions in such situations. Investigators propose to use OSA 18, a validated questionnaire that determines the effects of obstructive sleep apnea on pediatric quality of life, and subsequently measure caregivers' decision-making processes through a decisional conflict scale survey. Investigators believe that using this questionnaire may impact decision making for such patients and help reduce the DC.

This will be a randomized controlled trial (RCT).

Identification and Recruitment: Convenience sampling will be used for this study. The clinic lists will be scanned weekly by a member of the study team to identify patients with mild OSA. Consecutive patients/ families, meeting inclusion criteria will be invited to participate. Participants will be approached by a member of the study team on the day of visit or within 1 week of the visit by a telephone call to enlist participation.

Consent/Assent: Verbal consent will be obtained through the phone call and confirmed on the day of clinic visit and documented in the consent documentation form which will be locked away in a secure cabinet and also documented on the network drive. A secure REDCap database will also be used to document verbal consent in the instance that recruitment was done telephonically. Verbal consent will be obtained at the time of recruitment by a study team member. The team member will introduce the study and explain the purpose, the procedures, and how participants are randomly assigned to a group.

Retention: Participation last through the completion of all surveys. The surveys take approximately 5 minutes to complete.

Protocol:

At the start of the visit, families who consented to participate will be given a demographics questionnaire asking about age, race/ethnicity, and health literacy. BMI and sleep study data will also be recorded by a study team member. Following this survey, participants will follow the protocol for the group they are randomly assigned to, either case or control.

Case Group:

If in case group, parents will be asked to complete the OSA18 questionnaire. The total score along with category: mild, moderate or severe will be presented to the families along with scores for various domains. Families will then be provided with a printed form, "decision aid," at the time of consultation with various management options, detailing evidence based risks and benefits for each option. In the case group, this will include the OSA 18 total scores at the bottom this will also help standardized the discussion by the provider.

The decisional conflict scale (DCS) will be filled out at conclusion of visit after the provider has left the room. 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 by16, 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. The validation study indicates that a score ≥ 25 signifies a decisional conflict.

Control Group: Families in the control group will be provided with a printed form, "decision aid," at the time of consultation with various management options, detailing evidence based risks and benefits for each option.

The decisional conflict scale (DCS) will be filled out at conclusion of visit after the provider has left the room. 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 by16, 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. The validation study indicates that a score ≥ 25 signifies a decisional conflict.

Responses from all participants will be stored securely in a de-identifiable manner.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale (DCS)
Time Frame: Through clinical visit, an average of 30 minutes
The Decisional Conflict Scale (DCS) is a survey administered to both the experimental and active comparator evaluating the degree of conflict a caregiver feels when determining a treatment option. The minimum score is 0 (indicating no decisional conflict) and the maximum score is 100 (indicating significant decisional conflict).
Through clinical visit, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender of child and parent/legal guardian
Time Frame: Through clinical visit, an average of 30 minutes
  • Male
  • Female
  • Intersex
  • None of these describe my child
  • Prefer not to answer
Through clinical visit, an average of 30 minutes
Age of child and parent/legal guardian
Time Frame: Through clinical visit, an average of 30 minutes
years
Through clinical visit, an average of 30 minutes
Race/Ethnicity of child and parent/legal guardian
Time Frame: Through clinical visit, an average of 30 minutes
  • American Indian or Alaska Native
  • Asian
  • Black or African American
  • Hispanic or Latino
  • Native Hawaiian or Other Pacific Islander
  • White
  • Prefer not to answer
Through clinical visit, an average of 30 minutes
Parent/legal guardian identified health care literacy and comfort completing medical forms.
Time Frame: Through clinical visit, an average of 30 minutes
  • Extremely
  • Quite a bit
  • Somewhat
  • A little bit
  • Not at all
Through clinical visit, an average of 30 minutes
BMI percentile
Time Frame: Through clinical visit, an average of 30 minutes
BMI reported as kg/m^2 will be reported as a percent based on the growth chart.
Through clinical visit, an average of 30 minutes
BMI Z-score
Time Frame: Through clinical visit, an average of 30 minutes
number value of BMI z-score
Through clinical visit, an average of 30 minutes
Polysomnography (PSG) (Sleep Study Data), AHI
Time Frame: Through study completion, and average of 3 months
Apnea Hypopnea Index (AHI) will be recorded from the PSG. Value is reported as a real number.
Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), OAHI
Time Frame: Through study completion, and average of 3 months
Obstructive apnea hypopnea index (OAHI) will be recorded from the PSG. Values is reported as a real number.
Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), high CO2 occurrences
Time Frame: Through study completion, and average of 3 months
The number of times the patient has a CO2 level of >50mmHG during the course of the sleep study will be recorded.
Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), minimum oxygen saturation
Time Frame: Through study completion, and average of 3 months
The lowest oxygen saturation of the patient during the sleep study, sometimes called nadir O2, will be recorded.
Through study completion, and average of 3 months
Selected Treatment Option
Time Frame: Through clinical visit, an average of 30 minutes
Parent/Caregiver will choose between surgery, medication, watchful waiting, or undecided at their regularly scheduled clinical visit.
Through clinical visit, an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Collaborators

ResMed Foundation

Investigators

  • Principal Investigator: Nancy Grover, MD, Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-044 CCMC
  • ResMed Foundation (Other Grant/Funding Number: ResMed Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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