Sleep-Disordered BreathingNCT05353998
Efficacy of Clinical Decision Support and Sleep Navigation (Sleep PASS)
A study testing CDS with Sleep Navigation and CDS-only in people with Sleep-Disordered Breathing and Obstructive Sleep Apnea, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of the study is to examine the feasibility, acceptability, and initial outcomes of clinical decision support (CDS) and a Sleep Navigation program to enhance primary to specialty care management of pediatric sleep-disordered breathing (SDB). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep
- What is being tested?
- CDS with Sleep Navigation and CDS-only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregiver-child dyads:
- Child is between 2 years and 17 years of age
- Child has an abnormal SDB screen (i.e., a positive response to whether the child snores 3 or more nights/week) on the sleep screener used as part of well child visit care in the Children's Hospital of Philadelphia (CHOP) primary care network
- Child receives well child care at Cobbs Creek or Karabots CHOP primary care network sites
- Parental/guardian permission (informed consent) and if applicable, child assent
- Caregiver participant is the parent or legal guardian of the child subject
Show all 11Show fewer
- Caregiver is 18 years of age or older
- English-speaking
- Clinicians:
- Primary care clinician practicing at Cobbs Creek or Karabots CHOP primary care network sites
- English-speaking
Who cannot join
- Caregiver-child dyads:
- Caregiver is not the parent or legal guardian of child participant or is <18 years of age
- Non-English speaking, as intervention sessions and qualitative interviews will be conducted in English
- Child receives well child care at a non-participating primary care site at enrollment
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
- Clinicians:
- Does not see patients at Cobs Creek or Karabots CHOP primary care network sites
- Non-English speaking, as qualitative interviews will be conducted in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating the Efficacy of Clinical Decision Support and Sleep Navigation to Enhance Primary to Specialty Care Management of Sleep Disordered Breathing
The purpose of the study is to examine the feasibility, acceptability, and initial outcomes of clinical decision support (CDS) and a Sleep Navigation program to enhance primary to specialty care management of pediatric sleep-disordered breathing (SDB).
Read the detailed description
Sleep disordered breathing (SDB), which ranges from mild snoring to severe obstructive sleep apnea, impacts up to 17% of all children and is a significant public health concern. Untreated SDB is associated with significant risks to child health and well-being, including child neurobehavioral problems, hypertension, and obesity. Despite the robust evidence base for treating SDB, there are notable racial, ethnic, and socioeconomic disparities in its prevalence and treatment; even when SDB is identified in primary care visits, referral rates to specialty care are extremely low.
This is a randomized controlled trial of the Sleep PASS program, with the primary objectives to (1) determine the feasibility and acceptability of CDS for SDB in primary care, and (2) determine the feasibility and acceptability of Sleep Navigation for patients with SDB who meet criteria for further clinical evaluation. The secondary objective is to examine the initial efficacy of CDS and Sleep Navigation on referral rates and rates of referral completion for SDB-related specialty care, caregiver SDB knowledge, and child sleep for patients with SDB who meet criteria for further clinical evaluation. Up to 200 caregiver-child dyads with a child (ages 2 years 0 months to < 18 years) who has been screened for SDB symptoms in Children's Hospital of Philadelphia primary care and meets criteria for further clinical evaluation will be recruited. Up to 70 primary care clinicians will also be recruited.
Eligible and interested caregiver-child dyads will be randomly assigned to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition. The Sleep Navigation program will involve 1-3 meetings, conducted virtually, in-person, or via telephone, between the Sleep Navigator (SN) and the participating family. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.
Study procedures involves medical record review, caregiver- and child-completed questionnaires, clinician-completed questionnaires, interviews, and Navigator sessions (for the Intervention condition). Following sleep screening as part of well child visit care, electronic health records and the sleep screener will be reviewed for eligibility. Eligible and interested participants will be scheduled for a baseline assessment visit that occurs in-person or electronically and includes informed consent (or e-consent), random assignment to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition, and completion of baseline measures. The intervention group will start receiving the Sleep Navigation program 1-2 weeks following baseline assessment. The CDS only condition will be directed to follow up with their primary care clinician as needed. Post-intervention and follow-up assessment will occur within 8 months of baseline questionnaire completion. Clinicians will complete questionnaires at the post-intervention phase. Randomly selected caregiver-child dyads in the intervention condition and clinicians will be invited to participate in qualitative interviews.
- Conditions
- Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep
- Being tested
- CDS with Sleep Navigation, CDS-only
- Keywords
- Sleep Disordered Breathing, Sleep PASS
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDS with Sleep NavigationOther
The Sleep Navigation program will involve 1-3 meetings between the Sleep Navigator (SN) and the participating family. Participants will also complete baseline and post-intervention assessments, and about 10 to 15 caregivers will be randomly invited to participate in an interview on the acceptability and feasibility of the program. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.
CDS-onlyOther
Participants will complete baseline and post-intervention assessments. Participants will be able to follow-up with their primary care clinician as needed.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Navigation group | Experimental | Caregiver-child dyads in this study arm (intervention condition) will participate in the Sleep Navigation program. Receives: Other: CDS with Sleep Navigation |
| CDS-only group | Other | Caregiver-child dyads in this study arm (control group) will not participate in the Sleep Navigation program, but will be directed to follow up with their primary care clinician as needed. Receives: Other: CDS-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDS feasibility (proportion of patients screened for SDB at well child visits of all those eligible for screening at well child visits over the study period)
Proportion of patients screened for SDB at well child visits will be calculated with data from the electronic health records.
Measured: up to 12 months
Clinician Decision Support Acceptability
Clinician Decision Support acceptability will be measured through clinician-completed system usability survey.
This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=somewhat disagree; 3=neither agree or disagree; 4=somewhat agree; and 5=strongly agree) with a range in score from 12 to 60. Higher total scores indicate better acceptability.
Measured: up to 12 months
Acceptability of the CDS Tool
CDS acceptability will be measured by semi-structured qualitative interviews completed by the clinicians. Up to 15 primary care clinicians will be invited to participate in an interview focused on acceptability of the CDS tool. The interview includes multiple, open-ended questions completed by the clinician.
Measured: up to 12 months
Sleep Navigator feasibility (number of Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
Feasibility will be measured using data from the Sleep Navigator-completed intervention-specific fidelity checklist.
Measured: within 8 months of baseline assessment
Sleep Navigator feasibility (Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
Feasibility will be measured using data from the caregiver-completed qualitative interview.
Measured: within 8 months of baseline assessment
Acceptability of the Sleep Navigation program (Treatment Evaluation Inventory-Short Form)
Acceptability of the Sleep Navigation program will be measured through the Treatment Evaluation Inventory-Short Form that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 11 to 55. Higher total scores indicate better acceptability.
Measured: within 8 months of baseline assessment
Acceptability of the Sleep Navigation program (Multicultural Therapy Competency Inventory)
Sleep Navigation acceptability will be measured through the Multicultural Therapy Competency Inventory- Client Version questionnaire that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 5 to 25. Higher total scores indicate better outcomes.
Measured: within 8 months of baseline assessment
Secondary outcomes (9)
Sleep specialty care referral rates
The change in referral rates will be measured through the proportion of patients referred for SDB specialty care of those identified with sleep disordered breathing symptoms based on well visit sleep screener over the study period.
Measured: through study completion, an average of 1 year
Completion of sleep specialty care referral
The change in referral completion for child sleep disordered breathing care will be measured through the proportion of patients randomized to Sleep Navigation who complete their specialty care referral of those referred to specialty care.
Measured: through study completion, an average of 1 year
Caregiver knowledge of Sleep Disordered Breathing (SDB)
The magnitude and direction of change in caregiver knowledge of SDB will be measured through the obstructive Sleep Disordered Breathing and Adenotonsillectomy knowledge scale for caregivers. This measure is rated on a dichotomous scale (True/False) with a total raw score range of 0 to 39. Correct answers are summed to attain an overall percentage score representing the degree of knowledge level, with a minimum value of zero and a maximum of 100%. A higher percentage indicates better outcomes.
Measured: at baseline and within 8 months of baseline assessment
Child SDB symptoms: Pediatric Sleep Questionnaire
The magnitude and direction of change in child sleep will be measured through the Pediatric Sleep Questionnaire scores, the most validated questionnaire assessing children's SDB symptoms. This measure is rated on a dichotomous scale ("yes" = 1, "no" = 0, and "don't know"=missing). The result is a proportion that ranges from 0.0 to 1.0. Scores greater than 0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder.
Measured: at baseline and within 8 months of baseline assessment
Child sleep habits: Brief Child Sleep Questionnaire (BCSQ)
The magnitude and direction of change in child sleep will be measured through the BCSQ which assesses child sleep habits including sleep time, total sleep duration, night waking, aspects of the sleep environment, etc. The BCSQ uses a nominal scale system. Scores on each subscale and the total score are scaled from 0 to 100. Higher scores denote better sleep quality, more positive perception of child sleep, and parent behaviors that promote healthy and independent sleep.
Measured: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbances
The PROMIS Sleep Disturbances survey would measure the magnitude and direction of change in child sleep. This measure is rated on a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. The raw scores are converted to a standardized T-score, with higher scores indicating greater severity of sleep disturbance.
Measured: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment
The PROMIS Sleep-Related Impairment survey would measure the magnitude and direction of change in child sleep. This measure is rated on a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. The raw scores are converted to a standardized T-score, with higher scores indicating greater severity of sleep-related impairment.
Measured: at baseline and within 8 months of baseline assessment
Child sleep practices
Sleep practices would be assessed using the Patient-Reported Outcomes Measurement Information System Sleep Practices survey. This measure assesses 5 sleep practices: sleep timing, sleep routines and consistency, technology use before bedtime, sleep environment, and the need for parental presence to fall asleep. This measure is rated on a nominal scale and 5-point Likert scale. Scores on each subscale and the total score are scaled from 0 to 100. Higher scores indicate better sleep practices.
Measured: at baseline and within 8 months of baseline assessment
Child obstructive sleep apnea symptoms
The change in child obstructive sleep apnea (OSA) symptoms will be measured through the OSA-18, a validated caregiver-completed questionnaire. This measure is rated on a 7-point Likert scale. Total raw score ranges from 18 to 126. Higher scores indicates worse outcomes.
Measured: at baseline and within 8 months of baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregiver-child dyads with a child who meets criteria for further SDB evaluation will be randomly assigned (1:1) to either the intervention condition, which is the CDS and the Sleep Navigation program, or to a CDS only condition.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariel Williamson, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353998
- Sponsor's protocol ID
- 22-019762
- Status last verified
- Jul 2024
- First submitted
- 15 Mar 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Archbold KH, Pituch KJ, Panahi P, Chervin RD. Symptoms of sleep disturbances among children at two general pediatric clinics. J Pediatr. 2002 Jan;140(1):97-102. doi: 10.1067/mpd.2002.119990.
PubMed 11815771Rosen CL, Larkin EK, Kirchner HL, Emancipator JL, Bivins SF, Surovec SA, Martin RJ, Redline S. Prevalence and risk factors for sleep-disordered breathing in 8- to 11-year-old children: association with race and prematurity. J Pediatr. 2003 Apr;142(4):383-9. doi: 10.1067/mpd.2003.28.
PubMed 12712055Bonuck KA, Chervin RD, Cole TJ, Emond A, Henderson J, Xu L, Freeman K. Prevalence and persistence of sleep disordered breathing symptoms in young children: a 6-year population-based cohort study. Sleep. 2011 Jul 1;34(7):875-84. doi: 10.5665/SLEEP.1118.
PubMed 21731137Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
PubMed 22926173Boss EF, Smith DF, Ishman SL. Racial/ethnic and socioeconomic disparities in the diagnosis and treatment of sleep-disordered breathing in children. Int J Pediatr Otorhinolaryngol. 2011 Mar;75(3):299-307. doi: 10.1016/j.ijporl.2010.11.006. Epub 2011 Feb 4.
PubMed 21295865Meltzer LJ, Plaufcan MR, Thomas JH, Mindell JA. Sleep problems and sleep disorders in pediatric primary care: treatment recommendations, persistence, and health care utilization. J Clin Sleep Med. 2014 Apr 15;10(4):421-6. doi: 10.5664/jcsm.3620.
PubMed 24733988Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Clinical Decision Support and Sleep Navigation to Enhance Primary to Specialty Care Management of Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT05353998
- Acronym / sponsor ID
- 22-019762
- Conditions
- Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep
- Keywords
- Sleep Disordered Breathing, Sleep PASS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 29 Apr 2022 (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 purpose of the study is to examine the feasibility, acceptability, and initial outcomes of clinical decision support (CDS) and a Sleep Navigation program to enhance primary to specialty care management of pediatric sleep-disordered breathing (SDB).
Detailed description
Sleep disordered breathing (SDB), which ranges from mild snoring to severe obstructive sleep apnea, impacts up to 17% of all children and is a significant public health concern. Untreated SDB is associated with significant risks to child health and well-being, including child neurobehavioral problems, hypertension, and obesity. Despite the robust evidence base for treating SDB, there are notable racial, ethnic, and socioeconomic disparities in its prevalence and treatment; even when SDB is identified in primary care visits, referral rates to specialty care are extremely low.
This is a randomized controlled trial of the Sleep PASS program, with the primary objectives to (1) determine the feasibility and acceptability of CDS for SDB in primary care, and (2) determine the feasibility and acceptability of Sleep Navigation for patients with SDB who meet criteria for further clinical evaluation. The secondary objective is to examine the initial efficacy of CDS and Sleep Navigation on referral rates and rates of referral completion for SDB-related specialty care, caregiver SDB knowledge, and child sleep for patients with SDB who meet criteria for further clinical evaluation. Up to 200 caregiver-child dyads with a child (ages 2 years 0 months to < 18 years) who has been screened for SDB symptoms in Children's Hospital of Philadelphia primary care and meets criteria for further clinical evaluation will be recruited. Up to 70 primary care clinicians will also be recruited.
Eligible and interested caregiver-child dyads will be randomly assigned to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition. The Sleep Navigation program will involve 1-3 meetings, conducted virtually, in-person, or via telephone, between the Sleep Navigator (SN) and the participating family. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.
Study procedures involves medical record review, caregiver- and child-completed questionnaires, clinician-completed questionnaires, interviews, and Navigator sessions (for the Intervention condition). Following sleep screening as part of well child visit care, electronic health records and the sleep screener will be reviewed for eligibility. Eligible and interested participants will be scheduled for a baseline assessment visit that occurs in-person or electronically and includes informed consent (or e-consent), random assignment to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition, and completion of baseline measures. The intervention group will start receiving the Sleep Navigation program 1-2 weeks following baseline assessment. The CDS only condition will be directed to follow up with their primary care clinician as needed. Post-intervention and follow-up assessment will occur within 8 months of baseline questionnaire completion. Clinicians will complete questionnaires at the post-intervention phase. Randomly selected caregiver-child dyads in the intervention condition and clinicians will be invited to participate in qualitative interviews.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Caregiver-child dyads with a child who meets criteria for further SDB evaluation will be randomly assigned (1:1) to either the intervention condition, which is the CDS and the Sleep Navigation program, or to a CDS only condition.
| Arm | Type | Receives |
|---|---|---|
| Sleep Navigation group | Experimental | Other: CDS with Sleep NavigationCaregiver-child dyads in this study arm (intervention condition) will participate in the Sleep Navigation program. |
| CDS-only group | Other | Other: CDS-onlyCaregiver-child dyads in this study arm (control group) will not participate in the Sleep Navigation program, but will be directed to follow up with their primary care clinician as needed. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Child is between 2 years and 17 years of age
- Child has an abnormal SDB screen (i.e., a positive response to whether the child snores 3 or more nights/week) on the sleep screener used as part of well child visit care in the Children's Hospital of Philadelphia (CHOP) primary care network
- Child receives well child care at Cobbs Creek or Karabots CHOP primary care network sites
- Parental/guardian permission (informed consent) and if applicable, child assent
- Caregiver participant is the parent or legal guardian of the child subject
Key exclusion criteria (8 listed)
- Caregiver is not the parent or legal guardian of child participant or is <18 years of age
- Non-English speaking, as intervention sessions and qualitative interviews will be conducted in English
- Child receives well child care at a non-participating primary care site at enrollment
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
- Does not see patients at Cobs Creek or Karabots CHOP primary care network sites
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 |
|---|---|---|
| CDS with Sleep NavigationThe Sleep Navigation program will involve 1-3 meetings between the Sleep Navigator (SN) and the participating family. Participants will also complete baseline and post-intervention assessments, and about 10 to 15 caregivers will be randomly invited to participate in an interview on the acceptability and feasibility of the program. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team. | Other | Sleep Navigation group |
| CDS-onlyParticipants will complete baseline and post-intervention assessments. Participants will be able to follow-up with their primary care clinician as needed. | Other | CDS-only group |
Primary outcome
CDS feasibility (proportion of patients screened for SDB at well child visits of all those eligible for screening at well child visits over the study period)
Time frame: up to 12 months
Proportion of patients screened for SDB at well child visits will be calculated with data from the electronic health records.
Clinician Decision Support Acceptability
Time frame: up to 12 months
Clinician Decision Support acceptability will be measured through clinician-completed system usability survey. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=somewhat disagree; 3=neither agree or disagree; 4=somewhat agree; and 5=strongly agree) with a range in score from 12 to 60. Higher total scores indicate better acceptability.
Acceptability of the CDS Tool
Time frame: up to 12 months
CDS acceptability will be measured by semi-structured qualitative interviews completed by the clinicians. Up to 15 primary care clinicians will be invited to participate in an interview focused on acceptability of the CDS tool. The interview includes multiple, open-ended questions completed by the clinician.
Sleep Navigator feasibility (number of Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
Time frame: within 8 months of baseline assessment
Feasibility will be measured using data from the Sleep Navigator-completed intervention-specific fidelity checklist.
Sleep Navigator feasibility (Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
Time frame: within 8 months of baseline assessment
Feasibility will be measured using data from the caregiver-completed qualitative interview.
Acceptability of the Sleep Navigation program (Treatment Evaluation Inventory-Short Form)
Time frame: within 8 months of baseline assessment
Acceptability of the Sleep Navigation program will be measured through the Treatment Evaluation Inventory-Short Form that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 11 to 55. Higher total scores indicate better acceptability.
Acceptability of the Sleep Navigation program (Multicultural Therapy Competency Inventory)
Time frame: within 8 months of baseline assessment
Sleep Navigation acceptability will be measured through the Multicultural Therapy Competency Inventory- Client Version questionnaire that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 5 to 25. Higher total scores indicate better outcomes.
9 secondary outcomes
Sleep specialty care referral rates
Time frame: through study completion, an average of 1 year
Completion of sleep specialty care referral
Time frame: through study completion, an average of 1 year
Caregiver knowledge of Sleep Disordered Breathing (SDB)
Time frame: at baseline and within 8 months of baseline assessment
Child SDB symptoms: Pediatric Sleep Questionnaire
Time frame: at baseline and within 8 months of baseline assessment
Child sleep habits: Brief Child Sleep Questionnaire (BCSQ)
Time frame: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbances
Time frame: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment
Time frame: at baseline and within 8 months of baseline assessment
Child sleep practices
Time frame: at baseline and within 8 months of baseline assessment
Child obstructive sleep apnea symptoms
Time frame: at baseline and within 8 months of baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 11815771Archbold KH, Pituch KJ, Panahi P, Chervin RD. Symptoms of sleep disturbances among children at two general pediatric clinics. J Pediatr. 2002 Jan;140(1):97-102. doi: 10.1067/mpd.2002.119990.
- Background: PubMed 12712055Rosen CL, Larkin EK, Kirchner HL, Emancipator JL, Bivins SF, Surovec SA, Martin RJ, Redline S. Prevalence and risk factors for sleep-disordered breathing in 8- to 11-year-old children: association with race and prematurity. J Pediatr. 2003 Apr;142(4):383-9. doi: 10.1067/mpd.2003.28.
- Background: PubMed 21731137Bonuck KA, Chervin RD, Cole TJ, Emond A, Henderson J, Xu L, Freeman K. Prevalence and persistence of sleep disordered breathing symptoms in young children: a 6-year population-based cohort study. Sleep. 2011 Jul 1;34(7):875-84. doi: 10.5665/SLEEP.1118.
- Background: PubMed 22926173Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
- Background: PubMed 21295865Boss EF, Smith DF, Ishman SL. Racial/ethnic and socioeconomic disparities in the diagnosis and treatment of sleep-disordered breathing in children. Int J Pediatr Otorhinolaryngol. 2011 Mar;75(3):299-307. doi: 10.1016/j.ijporl.2010.11.006. Epub 2011 Feb 4.
- Background: PubMed 24733988Meltzer LJ, Plaufcan MR, Thomas JH, Mindell JA. Sleep problems and sleep disorders in pediatric primary care: treatment recommendations, persistence, and health care utilization. J Clin Sleep Med. 2014 Apr 15;10(4):421-6. doi: 10.5664/jcsm.3620.
- Derived from this study: PubMed 39382077Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
- 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. This study is not recruiting at the moment.
Ariel Williamson, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDS with Sleep Navigation and CDS-only in people with Sleep-Disordered Breathing and Obstructive Sleep Apnea, run by Children's Hospital of Philadelphia 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CDS feasibility (proportion of patients screened for SDB at well child visits of all those eligible for screening at well child visits over the study period) (time frame: up to 12 months). The study lists 7 primary outcomes in all. 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 NCT05353998, which also lists 7 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 12 Jul 2024.