Family-Informed Intervention for Obstructive Sleep Apnea in Children with Down Syndrome

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Leukemia, Severe heart disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

86 Participants Needed

Trial Summary

What is the purpose of this trial?

Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Family-informed intervention treatment for obstructive sleep apnea in children with Down syndrome?

The research highlights the importance of family-focused approaches in managing obstructive sleep apnea (OSA) in children with Down syndrome, as families play a crucial role in treatment adherence and healthcare experiences. While specific data on the Family-informed intervention is not provided, the emphasis on family involvement in healthcare suggests that such interventions could improve treatment outcomes by enhancing adherence and support. ^{1 2 3 4 5}

How is the Family-Informed Intervention treatment for obstructive sleep apnea in children with Down syndrome different from other treatments?

The Family-Informed Intervention treatment is unique because it involves the family in the care process, focusing on education and support to improve adherence and outcomes, unlike traditional treatments like surgery or CPAP (a machine that helps keep the airway open during sleep) which do not typically involve family-centered approaches. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for children aged 6-18 with Down Syndrome and obstructive sleep apnea who haven't used PAP treatment before. They must be able to do tests and have a clinical referral for PAP. It's not for kids in foster care, those treated with PAP already, or with major illnesses like leukemia or severe heart disease.

Inclusion Criteria

I have never received PAP treatment.

My child can follow instructions for tests.

I am between 6 and 18 years old.

Exclusion Criteria

I am a caregiver and I do not speak English well enough for medical assessments.

My child was previously treated with PAP.

Children who are in the care of the foster system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive family-informed intervention (INT) or standard clinical care to promote PAP adherence

12 months

Multiple face-to-face visits, telephone calls, and in-person visits

Follow-up

Participants are monitored for PAP adherence, quality of life, and neurobehavioral outcomes

12 months

Assessments at baseline, 6 months, and 12 months

Treatment Details

Interventions

• Family-informed intervention
• Standard Clinical Care

Trial Overview The study compares the effectiveness of a family-informed intervention versus standard clinical care over twelve months in treating sleep apnea in children with Down Syndrome.

Participant Groups

Group I: Family-informed intervention (INT) Active Control 1 Intervention

Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.

Group II: Standard Clinical Care Active Control 1 Intervention

Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Family-informed intervention is already approved in United States for the following indications:

Approved in United States as Family-informed intervention for:

• Improving adherence to PAP therapy in children with Down syndrome and obstructive sleep apnea

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Parents of children with Down Syndrome often normalize sleep difficulties, viewing them as a typical challenge of parenting, which can lead to underreporting and inadequate treatment of these issues.

Healthcare professionals frequently reinforce this normalization, resulting in insufficient care and missed opportunities for referrals to specialized sleep services, highlighting the need for increased awareness and proactive approaches in addressing sleep disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' Experiences of Having a Child with Down Syndrome and Sleep Difficulties. Chawla, JK., Cooke, E., Miguel, MC., et al.[2023]

Obstructive sleep apnea (OSA) is common in children, particularly those with Down syndrome and other comorbidities, highlighting the need for family-focused evaluations and innovative diagnostic methods.

Therapeutic options for treating OSA in children are limited, but recent studies suggest that hypoglossal nerve stimulation may be a promising treatment, alongside traditional positive airway pressure methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's New in Pediatric Obstructive Sleep Apnea? Cielo, CM., Tapia, IE.[2023]

Among 954 children with Down syndrome, 39.1% were diagnosed with sleep problems, but only 47.7% underwent necessary overnight sleep studies (polysomnography) to confirm these issues.

Of those diagnosed with sleep problems, 81.2% received appropriate interventions, indicating that while treatment matched diagnoses, there is a need for improved screening and referral practices, especially considering age and gender disparities in treatment rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Sleep Evaluations and Treatments in Children with Down Syndrome. Esbensen, AJ., Beebe, DW., Byars, KC., et al.[2018]

Adeno-tonsillectomy (T&A) in children with Down syndrome (DS) led to some improvement in obstructive sleep apnea (OSA) parameters, but these improvements were less significant compared to non-DS children, indicating a limited efficacy of the procedure for DS patients.

While 27% of DS children experienced enough improvement to avoid further treatment after T&A, a significant 73% still required additional interventions like CPAP or BiPAP for ongoing OSA, highlighting the need for continued management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of adeno-tonsillectomy on polysomnography patterns in Down syndrome children with obstructive sleep apnea: a comparative study with children without Down syndrome. Shete, MM., Stocks, RM., Sebelik, ME., et al.[2022]

Children with Down syndrome (DS) showed significantly greater adherence to noninvasive ventilation (NIV) for obstructive sleep apnea (OSA) compared to non-DS children, with an average usage of 78.95% of days versus 72.11%.

Despite better adherence, children with DS experienced poorer clinical outcomes, indicated by a higher apnea-hypopnoea index (AHI) and greater leakage from the NIV system, suggesting that while they use the device more consistently, issues like excessive leakage may reduce its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and adherence of noninvasive ventilation treatment in children with Down syndrome. MacDonagh, L., Farrell, L., O'Reilly, R., et al.[2021]

Level II home sleep apnea testing (HSAT) is feasible and well-accepted among youth with Down syndrome, with 73.7% of parents preferring it over traditional in-lab polysomnography.

HSAT demonstrated good accuracy in detecting moderate to severe obstructive sleep apnea (OSA), with a sensitivity of 81% and specificity of 75%, making it a viable alternative for evaluating OSA in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and performance of home sleep apnea testing in youth with Down syndrome. Cielo, CM., Kelly, A., Xanthopoulos, M., et al.[2023]

In a study of 19 young patients with Down syndrome, 79% were found to have obstructive sleep apnea (OSA), indicating a high prevalence of this condition in this population.

The study revealed significant associations between OSA and factors such as higher body mass index, age, and poor sleep quality, highlighting the need for further research to improve treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective polysomnographic analysis of obstructive sleep apnea in down syndrome. Dyken, ME., Lin-Dyken, DC., Poulton, S., et al.[2013]

In a study of five children with Down syndrome suffering from obstructive sleep apnea, it was found that their altered anatomy contributed to the condition, particularly affecting the oropharynx, cranium, and midface.

A modified pharyngopalatal surgical approach was effective in relieving upper airway obstruction in these patients, suggesting that traditional tonsillectomy and adenoidectomy may not be sufficient for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea in Down syndrome children: a surgical approach. Strome, M.[2022]

Individuals with Down syndrome (DS) have a higher prevalence and severity of obstructive sleep apnea (OSA), necessitating routine screening for all DS patients due to the potential for serious health consequences.

Polysomnography is the gold standard for diagnosing OSA in DS, and treatment options include adenotonsillectomy and CPAP, with emerging therapies like hypoglossal nerve stimulation showing promise for difficult cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea in patients with Down syndrome: current perspectives. Simpson, R., Oyekan, AA., Ehsan, Z., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Parents' Experiences of Having a Child with Down Syndrome and Sleep Difficulties. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

What's New in Pediatric Obstructive Sleep Apnea? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Use of Sleep Evaluations and Treatments in Children with Down Syndrome. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Effects of adeno-tonsillectomy on polysomnography patterns in Down syndrome children with obstructive sleep apnea: a comparative study with children without Down syndrome. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and adherence of noninvasive ventilation treatment in children with Down syndrome. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility and performance of home sleep apnea testing in youth with Down syndrome. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Prospective polysomnographic analysis of obstructive sleep apnea in down syndrome. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea in Down syndrome children: a surgical approach. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea in patients with Down syndrome: current perspectives. [2020]