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

NCT05911646 | Recruiting

• 2 other identifiers: 21-044 CCMCResMed Foundation
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Mild Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS)

  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 Outcomes (11)

• Gender of child and parent/legal guardian

  Through clinical visit, an average of 30 minutes

• Age of child and parent/legal guardian

  Through clinical visit, an average of 30 minutes

• Race/Ethnicity of child and parent/legal guardian

  Through clinical visit, an average of 30 minutes

• Parent/legal guardian identified health care literacy and comfort completing medical forms.

  Through clinical visit, an average of 30 minutes

• BMI percentile

  Through clinical visit, an average of 30 minutes

Study Arms (2)

OSA-18 Case Group

EXPERIMENTAL

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; Other: Decisional Conflict (DCS)

Control Group

ACTIVE COMPARATOR

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)

Interventions

OSA-18 Survey OTHER

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.

OSA-18 Case Group

Decisional Conflict (DCS) OTHER

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.

Control Group; OSA-18 Case Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• ResMed Foundation: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (10)

• Bluher AE, Brawley CC, Cunningham TD, Baldassari CM. Impact of montelukast and fluticasone on quality of life in mild pediatric sleep apnea. Int J Pediatr Otorhinolaryngol. 2019 Oct;125:66-70. doi: 10.1016/j.ijporl.2019.06.027. Epub 2019 Jun 26.

  PMID: 31260810 BACKGROUND

• Volsky PG, Woughter MA, Beydoun HA, Derkay CS, Baldassari CM. Adenotonsillectomy vs observation for management of mild obstructive sleep apnea in children. Otolaryngol Head Neck Surg. 2014 Jan;150(1):126-32. doi: 10.1177/0194599813509780. Epub 2013 Oct 29.

  PMID: 24170659 BACKGROUND

• Redline S, Amin R, Beebe D, Chervin RD, Garetz SL, Giordani B, Marcus CL, Moore RH, Rosen CL, Arens R, Gozal D, Katz ES, Mitchell RB, Muzumdar H, Taylor HG, Thomas N, Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. Sleep. 2011 Nov 1;34(11):1509-17. doi: 10.5665/sleep.1388.

  PMID: 22043122 BACKGROUND

• Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

  PMID: 22869829 BACKGROUND

• Kheirandish-Gozal L, Bandla HP, Gozal D. Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial. Ann Am Thorac Soc. 2016 Oct;13(10):1736-1741. doi: 10.1513/AnnalsATS.201606-432OC.

  PMID: 27439031 BACKGROUND

• Kheirandish-Gozal L, Bhattacharjee R, Bandla HPR, Gozal D. Antiinflammatory therapy outcomes for mild OSA in children. Chest. 2014 Jul;146(1):88-95. doi: 10.1378/chest.13-2288.

  PMID: 24504096 BACKGROUND

• Chan CC, Au CT, Lam HS, Lee DL, Wing YK, Li AM. Intranasal corticosteroids for mild childhood obstructive sleep apnea--a randomized, placebo-controlled study. Sleep Med. 2015 Mar;16(3):358-63. doi: 10.1016/j.sleep.2014.10.015. Epub 2015 Jan 15.

  PMID: 25650159 BACKGROUND

• Bergeron M, Duggins AL, Cohen AP, Tiemeyer K, Mullen L, Crisalli J, McArthur A, Ishman SL. A shared decision-making tool for obstructive sleep apnea without tonsillar hypertrophy: A randomized controlled trial. Laryngoscope. 2018 Apr;128(4):1007-1015. doi: 10.1002/lary.26967. Epub 2017 Nov 8.

  PMID: 29114896 BACKGROUND

• Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254.

  PMID: 10889473 BACKGROUND

• Chang SJ, Chae KY. Obstructive sleep apnea syndrome in children: Epidemiology, pathophysiology, diagnosis and sequelae. Korean J Pediatr. 2010 Oct;53(10):863-71. doi: 10.3345/kjp.2010.53.10.863. Epub 2010 Oct 31.

  PMID: 21189956 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nancy Grover, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Grover, MD

CONTACT

860- 545- 9650; ngrover@connecticutchildrens.org

Cameron King, MA

CONTACT

8608375595; CKing02@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Otolaryngologist, Assistant Professor of Otolaryngology

Model Details: A simple, fixed randomization will be performed using an excel spreadsheet. A randomization formula will be used to assign each new participant a number 1 or 2. All individuals assigned the number "1" will be designated as control and all individuals assigned the number "2" will be designated as case. The randomization will continue until 65 participants is reached for one group. At that time, any new recruited patients will be automatically assigned either control or case, depending on which group has not reached 65 participants. The randomization will be done at the time of consenting.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 22, 2023
• Study Start: June 2, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)