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

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Leukemia, Severe heart disease, others

No Placebo Group

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}

Research Team

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.

Trial 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 (Behavioral Intervention)
• Standard Clinical Care (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Cincinnati Children's Hospital Medical Center Cincinnati, OH

The Children's Hospital of Philadelphia Philadelphia, PA

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Patients Recruited

423,000+

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Patients Recruited

11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Patients Recruited

6,566,000+

University of Pennsylvania

Collaborator

Trials

2118

Patients Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2896

Patients Recruited

8,053,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]