Sleep Questionnaire Validation for Down Syndrome

Overseen By Derek Lam, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Tracheostomy, Tracheal stenosis, Cardiopulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to validate questionnaires for assessing sleep issues in children with Down syndrome, who often experience sleep disturbances like obstructive sleep apnea (OSA). Caregivers will complete questionnaires, and their children will undergo sleep studies (a type of diagnostic test) to better understand and improve sleep-related quality of life. Children with Down syndrome, aged 2-17, who are part of the Down syndrome clinic at OHSU and have had a recent sleep study or will have one, qualify for participation. As an unphased trial, this study offers families a unique opportunity to contribute to research that could enhance sleep quality for children with Down syndrome.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on validating sleep questionnaires for children with Down syndrome, so it's best to ask the trial coordinators for more details.

What prior data suggests that this sleep study is safe for pediatric Down syndrome patients?

Research has shown that sleep studies are commonly used to check for sleep problems, such as obstructive sleep apnea (OSA), in children with Down syndrome. These studies are safe. The American Academy of Pediatrics, for instance, advises that all children with Down syndrome undergo a sleep study to check for OSA by age four. This recommendation underscores the safety and importance of sleep studies for these children.

During a sleep study, doctors monitor a child's sleep, including breathing and other vital signs, overnight. The process is non-invasive, meaning nothing enters the body, and most children tolerate it well. Major side effects are not usually reported, making sleep studies a safe method for investigating sleep issues in children with Down syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how we understand and manage sleep issues in individuals with Down syndrome. Unlike traditional methods, which may not fully capture the unique sleep challenges faced by this group, this trial uses specialized questionnaires and sleep studies to gather more precise data. By validating these tools, the trial could lead to better-tailored treatments and interventions, ultimately enhancing the quality of life for those affected by Down syndrome.

What evidence suggests that this sleep study is effective for assessing OSA in Down syndrome patients?

Research shows that many children with Down syndrome experience sleep problems, including obstructive sleep apnea (OSA), more frequently than other children. Studies have found that 53% to 76% of children with Down syndrome have OSA, compared to only 2% to 6% of children in the general population. In this trial, caregivers will complete questionnaires and participate in sleep studies to help researchers understand these sleep patterns and diagnose OSA. These studies reveal that children with Down syndrome often sleep less overall and take longer to reach REM sleep, which is crucial for feeling well-rested. Addressing these sleep issues can significantly improve the quality of life for children with Down syndrome. ^{2 3 6 7 8}

Who Is on the Research Team?

Derek Lam, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for children with Down syndrome aged 2-17 years who visit the Down syndrome clinic at OHSU/Doernbecher's. They must have had a recent sleep study or be scheduled for one, and their caregivers need to read English or Spanish. Kids with tracheostomy, airway narrowing, or severe heart/lung disease needing extra oxygen can't join.

Inclusion Criteria

My child with Down syndrome is between 2-17 years old and is seen at the Oregon Health and Science University.

My child has had a sleep study in the last 6 months and hasn't had surgery for sleep apnea since.

Exclusion Criteria

I have a narrowing in my windpipe.

I have a tracheostomy.

Parents or caregivers who are unable to read written English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Caregivers complete SRBD-PSQ, OSA-18, and PedsQL questionnaires; initial sleep study is conducted

1 month

1 visit (in-person)

Follow-up Assessment

Second sleep study conducted if needed, and follow-up questionnaires administered

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep study

Trial Overview The study aims to validate sleep questionnaires used in pediatric patients with Down syndrome by comparing questionnaire results with actual sleep studies. This helps understand the impact of obstructive sleep apnea on these kids' lives and check how well treatments are working.

How Is the Trial Designed?

Group I: Questionnaires and sleep studies Experimental Treatment 1 Intervention

Caregivers of patients meeting eligibility criteria will be invited to participate. If they agree to participate, baseline SRBD-PSQ, OSA-18, and PedsQL questionnaires along with written informed consent forms will be mailed to them along with their standard scheduling paperwork. Caregivers will be asked to review the consent form and complete the questionnaires and bring the paperwork to clinic on the day of their visit. Sleep study testing will also be ordered prior to their visit so that it can be scheduled within a month of the initial clinic visit and again three months later.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8021597/

Sleep Architecture in Children With Down Syndrome ... In children with Down syndrome, 32.5% had sleep efficiency <80%; 75.6% had an elevated arousal index; and 15.9% had total sleep time <360 ...

2. publications.aap.org publications.aap.org/pediatricsopenscience/article/doi/10.1542/pedsos.2024-000296/200819/Sleep-Study-Patterns-in-Children-With-Down

Sleep Study Patterns in Children With Down Syndrome at ... Children with DS in all age groups had prolonged REM latency. Polysomnographic findings showed significantly lower total sleep time (P < .001), ...

3. healthsciences.arizona.edu healthsciences.arizona.edu/news/releases/10m-pcori-award-fund-study-sleep-apnea-down-syndrome

$10M PCORI funding award will fuel study of sleep apnea ... Studies have suggested 53% to 76% of children and more than 80% of adults with Down syndrome have OSA, compared with about 2% to 6% of children ...

4. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/down-syndrome-sleep-apnea-study

Case Study of 4-Year-Old with Down Syndrome and Sleep ... After one month, Theo experienced an improvement in sleep, and his obstructive apnea-hypopnea index (a measure of apnea severity) decreased by ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06851338

Pediatric Down Syndrome Post-Approval Study The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130008S090b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) After initial therapy optimization, patients were followed by annual visits to assess effectiveness of the therapy with PSG or home sleep apnea ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6143127/

Obstructive sleep apnea in patients with Down syndrome 45 A separate study with data available on eleven DS individuals showed that 81% of patients had CPAP usage >4 hours per night 1–3 years ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132213/

Adherence to Guidelines for Screening Polysomnography in ... The AAP currently recommends universal screening of all children with DS for OSA with PSG obtained by 4 years of age.