Apnea, Obstructive SleepOSA-18NCT05911646
OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
A study testing OSA-18 Survey and Decisional Conflict (DCS) in people with Apnea, Obstructive Sleep and Obstructive Sleep Apnea, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea, Obstructive Sleep, Obstructive Sleep Apnea
- What is being tested?
- OSA-18 Survey and Decisional Conflict (DCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Nancy Grover, MD, ngrover@connecticutchildrens.org
About this study
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.
Read the 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.
- Conditions
- Apnea, Obstructive Sleep, Obstructive Sleep Apnea
- Being tested
- OSA-18 Survey, Decisional Conflict (DCS)
- Keywords
- Mild Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSA-18 SurveyOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Decisional Conflict (DCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through clinical visit, an average of 30 minutes
Secondary outcomes (11)
Gender of child and parent/legal guardian
- Male
- Female
- Intersex
- None of these describe my child
- Prefer not to answer
Measured: Through clinical visit, an average of 30 minutes
Age of child and parent/legal guardian
years
Measured: Through clinical visit, an average of 30 minutes
Race/Ethnicity of child and parent/legal guardian
- American Indian or Alaska Native
- Asian
- Black or African American
- Hispanic or Latino
- Native Hawaiian or Other Pacific Islander
- White
- Prefer not to answer
Measured: Through clinical visit, an average of 30 minutes
Parent/legal guardian identified health care literacy and comfort completing medical forms.
- Extremely
- Quite a bit
- Somewhat
- A little bit
- Not at all
Measured: Through clinical visit, an average of 30 minutes
BMI percentile
BMI reported as kg/m^2 will be reported as a percent based on the growth chart.
Measured: Through clinical visit, an average of 30 minutes
BMI Z-score
number value of BMI z-score
Measured: Through clinical visit, an average of 30 minutes
Polysomnography (PSG) (Sleep Study Data), AHI
Apnea Hypopnea Index (AHI) will be recorded from the PSG. Value is reported as a real number.
Measured: Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), OAHI
Obstructive apnea hypopnea index (OAHI) will be recorded from the PSG. Values is reported as a real number.
Measured: Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), high CO2 occurrences
The number of times the patient has a CO2 level of >50mmHG during the course of the sleep study will be recorded.
Measured: Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), minimum oxygen saturation
The lowest oxygen saturation of the patient during the sleep study, sometimes called nadir O2, will be recorded.
Measured: Through study completion, and average of 3 months
Selected Treatment Option
Parent/Caregiver will choose between surgery, medication, watchful waiting, or undecided at their regularly scheduled clinical visit.
Measured: Through clinical visit, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start2 Jun 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Apnea, Obstructive SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed Foundation
- Responsible party
- Principal investigator, Nancy Grover, Connecticut Children's Medical Center
- Investigators
- Nancy Grover, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911646
- Sponsor's protocol ID
- 21-044 CCMC
- Other IDs
- ResMed Foundation
- Acronym
- OSA-18
- Status last verified
- May 2026
- First submitted
- 26 Apr 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31260810Volsky 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.
PubMed 24170659Redline 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.
PubMed 22043122Goldbart 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.
PubMed 22869829Kheirandish-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.
PubMed 27439031Kheirandish-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.
PubMed 24504096Chan 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.
PubMed 25650159Bergeron 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.
PubMed 29114896Franco 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.
PubMed 10889473Chang 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.
PubMed 21189956
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
- ClinicalTrials.gov ID
- NCT05911646
- Acronym / sponsor ID
- OSA-18 / 21-044 CCMC
- Conditions
- Apnea, Obstructive Sleep, Obstructive Sleep Apnea
- Keywords
- Mild Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- ResMed Foundation
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| OSA-18 Case Group | Experimental | Other: OSA-18 Survey, Other: Decisional Conflict (DCS)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. |
| Control Group | Active comparator | Other: Decisional Conflict (DCS)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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSA-18 SurveyOSA 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 | OSA-18 Case Group |
| 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. | Other | Control Group, OSA-18 Case Group |
Primary outcome
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).
11 secondary outcomes
Gender of child and parent/legal guardian
Time frame: 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
Race/Ethnicity of child and parent/legal guardian
Time frame: 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
BMI percentile
Time frame: Through clinical visit, an average of 30 minutes
BMI Z-score
Time frame: Through clinical visit, an average of 30 minutes
Polysomnography (PSG) (Sleep Study Data), AHI
Time frame: Through study completion, and average of 3 months
Polysomnography (PSG) (Sleep Study Data), OAHI
Time frame: 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
Polysomnography (PSG) (Sleep Study Data), minimum oxygen saturation
Time frame: Through study completion, and average of 3 months
Selected Treatment Option
Time frame: Through clinical visit, an average of 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 31260810Bluher 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.
- Background: PubMed 24170659Volsky 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.
- Background: PubMed 22043122Redline 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.
- Background: PubMed 22869829Goldbart 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.
- Background: PubMed 27439031Kheirandish-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.
- Background: PubMed 24504096Kheirandish-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.
- Background: PubMed 25650159Chan 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.
- Background: PubMed 29114896Bergeron 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.
- Background: PubMed 10889473Franco 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.
- Background: PubMed 21189956Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Grover, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSA-18 Survey and Decisional Conflict (DCS) in people with Apnea, Obstructive Sleep and Obstructive Sleep Apnea, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Grover, MD (860- 545- 9650, ngrover@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) (time frame: Through clinical visit, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911646, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.