Obstructive Sleep Apnea of ChildNCT05908110
Evidence-based Pediatric Obstructive Sleep Apnea Detection
A study testing Health Communication Message in people with Obstructive Sleep Apnea of Child, run by Indiana University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Health Communication Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 10 Nov 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 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child ages 2.0-13.9 years at the time of OSA screening.
- Child is a primary care patient at Eskenazi Health
- Parent completed pre-visit questionnaire with OSA screening items
- Child screened positive for OSA (snoring >= 3 nights/wk + 1 additional symptom)
Who cannot join
- Prior OSA diagnosis
- Prior OSA referral (ENT, PSG, Sleep medicine) in the past two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: The Role of Health Communication Messaging in Evidence-based Pediatric Obstructive Sleep Apnea Detection
The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:
- Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
- Does the use of a health communication message help health care systems identify more children with OSA?
Read more
Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.
In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).
Researchers will compare groups to see if the health communication message helps identify more children with OSA.
Read the detailed description
Many children with obstructive sleep apnea (OSA) are not identified and thus do not receive treatment. In a previous study, the investigators found that a clinical decision support system helped primary care providers (PCPs) identify children with obstructive sleep apnea (OSA). In this system, parents of children report on possible OSA symptoms (e.g., snoring, sleepiness) in their child before the visit. If the child has OSA symptoms, the PCP receives an alert during the visit recommending further evaluation and a possible referral for a sleep study or to see a specialist. While this system helped increase the number of children with OSA symptoms who received a referral, many children remained unidentified. The goal of this study is to see whether involving parents in the system can identify even more children.
In this study, the investigators propose to test the impact of a health communication message, designed to educate and activate parents about their child's risk for OSA. This message is an infographic that helps parents recognize nighttime symptoms of OSA and how these nighttime symptoms may be impacting their child during the day. If a child has OSA symptoms, parents would view this infographic before their child's PCP visit and could discuss OSA with their child's PCP. For children with OSA symptoms, their parents will be randomized to either: 1) view the health communication message, or; 2) usual care, in which parents are not given any additional information about OSA or their child's risk prior to the appointment. In both cases, PCPs will receive a prompt indicating that the child is at risk for OSA.
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Health Communication Message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Communication MessageBehavioural
The health communication message is a single infographic developed iteratively with input from stakeholders (parents and providers). This image informs the parent that their child may have OSA, lists common nighttime symptoms parents may observe (e.g., snoring, apnea) and common daytime symptoms (e.g., hyperactivity, sleepiness) that can result from OSA. Parents are then encouraged to speak to their child's primary care provider if they observe these symptoms in their child.
| Study group | Role | What they receive |
|---|---|---|
| Health Communication Message | Experimental | Parents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA. Receives: Behavioral: Health Communication Message |
| Usual Care | No intervention | Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Completed OSA referral
Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
Measured: Up to 12 months after study entry (date of positive OSA screen)
Secondary outcomes (5)
Rate of OSA referral
Rate of children who received referral for sleep-disordered breathing, amongst whose who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
Measured: Up to 3 months after study entry (date of positive screen)
Rate of Evidence-based Evaluation
Rate of child who received evidence-based evaluation for pediatric OSA, amongst those who screened positive for OSA. Evidence-based evaluation includes 1) OSA referral; 2) documented watchful waiting with follow-up plan; and/or 3) documentation of evaluation not consistent with sleep-disordered breathing.
Measured: Up to 3 months after study entry (date of positive screen)
Rate of OSA Diagnosis
Rate of children who received an OSA diagnosis (verified via polysomnogram; apnea hypopnea index >1.5), amongst those who screened positive for OSA.
Measured: Up to 12 months after study entry (date of positive screen)
Rate of OSA Treatment
Rate of children receiving OSA treatment, amongst those who screened positive for OSA. Treatment to include 1) surgical intervention; 2) CPAP; 3) dental device; and/or 4) medication.
Measured: Up to 18 months after study entry (date of positive screen)
Rate of Parent Activation
Rate of parents who report planning to speak with child's provider about OSA, amongst those who viewed the health communication message. This will be measured by parental response to an item asking if they plan to speak with their child's provider about OSA, presented at the time that the parent reviews the health communication message.
Measured: Immediately after intervention (viewing the Health Communication Message)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start21 Jun 2023
- Primary completion10 May 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of ChildStudies 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
- Participants will be assigned to: 1) intervention (seeing a health communication message about OSA) or 2) Usual care.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health
- Responsible party
- Principal investigator, Sarah Honaker, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908110
- Sponsor's protocol ID
- 14456, 31533
- Other IDs
- K23HL150299-01
- Status last verified
- May 2026
- First submitted
- 22 May 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share data consistent with the requirements of the funder (NHLBI) and my institution.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Health Communication Messaging in Evidence-based Pediatric Obstructive Sleep Apnea Detection
- ClinicalTrials.gov ID
- NCT05908110
- Acronym / sponsor ID
- 14456, 31533
- Conditions
- Obstructive Sleep Apnea of Child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 18 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 goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:
- Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
- Does the use of a health communication message help health care systems identify more children with OSA?
Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.
In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).
Researchers will compare groups to see if the health communication message helps identify more children with OSA.
Detailed description
Many children with obstructive sleep apnea (OSA) are not identified and thus do not receive treatment. In a previous study, the investigators found that a clinical decision support system helped primary care providers (PCPs) identify children with obstructive sleep apnea (OSA). In this system, parents of children report on possible OSA symptoms (e.g., snoring, sleepiness) in their child before the visit. If the child has OSA symptoms, the PCP receives an alert during the visit recommending further evaluation and a possible referral for a sleep study or to see a specialist. While this system helped increase the number of children with OSA symptoms who received a referral, many children remained unidentified. The goal of this study is to see whether involving parents in the system can identify even more children.
In this study, the investigators propose to test the impact of a health communication message, designed to educate and activate parents about their child's risk for OSA. This message is an infographic that helps parents recognize nighttime symptoms of OSA and how these nighttime symptoms may be impacting their child during the day. If a child has OSA symptoms, parents would view this infographic before their child's PCP visit and could discuss OSA with their child's PCP. For children with OSA symptoms, their parents will be randomized to either: 1) view the health communication message, or; 2) usual care, in which parents are not given any additional information about OSA or their child's risk prior to the appointment. In both cases, PCPs will receive a prompt indicating that the child is at risk for OSA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to: 1) intervention (seeing a health communication message about OSA) or 2) Usual care.
| Arm | Type | Receives |
|---|---|---|
| Health Communication Message | Experimental | Behavioral: Health Communication MessageParents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA. |
| Usual Care | No intervention | –Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA. |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child ages 2.0-13.9 years at the time of OSA screening.
- Child is a primary care patient at Eskenazi Health
- Parent completed pre-visit questionnaire with OSA screening items
- Child screened positive for OSA (snoring >= 3 nights/wk + 1 additional symptom)
Key exclusion criteria (2 listed)
- Prior OSA diagnosis
- Prior OSA referral (ENT, PSG, Sleep medicine) in the past two years
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 |
|---|---|---|
| Health Communication MessageThe health communication message is a single infographic developed iteratively with input from stakeholders (parents and providers). This image informs the parent that their child may have OSA, lists common nighttime symptoms parents may observe (e.g., snoring, apnea) and common daytime symptoms (e.g., hyperactivity, sleepiness) that can result from OSA. Parents are then encouraged to speak to their child's primary care provider if they observe these symptoms in their child. | Behavioural | Health Communication Message |
Primary outcome
Rate of Completed OSA referral
Time frame: Up to 12 months after study entry (date of positive OSA screen)
Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
5 secondary outcomes
Rate of OSA referral
Time frame: Up to 3 months after study entry (date of positive screen)
Rate of Evidence-based Evaluation
Time frame: Up to 3 months after study entry (date of positive screen)
Rate of OSA Diagnosis
Time frame: Up to 12 months after study entry (date of positive screen)
Rate of OSA Treatment
Time frame: Up to 18 months after study entry (date of positive screen)
Rate of Parent Activation
Time frame: Immediately after intervention (viewing the Health Communication Message)
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 20 May 2026.
- Individual participant dataSharing planned: Yes. Will share data consistent with the requirements of the funder (NHLBI) and my institution.
Related trials for Obstructive Sleep Apnea of Child
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruiting
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea
RecruitingObservational study
SUNOSI® (Solriamfetol) Pregnancy Registry
Narcolepsy, Obstructive Sleep Apnea
RecruitingObservational study
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Sleep Apnea, Obstructive
RecruitingPhase 2
Down Syndrome Obstructive Sleep Apnea
Down Syndrome, Obstructive Sleep Apnea
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Communication Message in people with Obstructive Sleep Apnea of Child, run by Indiana University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Completed OSA referral (time frame: Up to 12 months after study entry (date of positive OSA screen)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.