230 Participants Needed

Oxygen Therapy for Down Syndrome with Sleep Apnea

(DOSA Trial)

Recruiting at 6 trial locations
OS
SH
RA
Overseen ByRaouf Amin, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Is oxygen therapy safe for children with sleep apnea?

Research suggests that supplemental oxygen might be a safe and beneficial temporary treatment for children with obstructive sleep apnea, as it improves oxygen levels and reduces breathing issues during sleep. However, it may also affect the body's natural response to low oxygen, so careful monitoring is important.12345

How is oxygen therapy unique for treating sleep apnea in Down syndrome?

Oxygen therapy is unique for treating sleep apnea in Down syndrome because it provides supplemental oxygen directly, which can be beneficial for those who may not tolerate other treatments like CPAP (continuous positive airway pressure) or surgery. It is a non-invasive option that can be used when other treatments are not suitable or effective.16789

What data supports the effectiveness of the treatment Oxygen, O2, for Down Syndrome with Sleep Apnea?

Supplemental oxygen has been shown to improve oxygenation and reduce breathing difficulties during sleep in children with obstructive sleep apnea, suggesting it might be beneficial for those with Down syndrome and similar conditions.12101112

Who Is on the Research Team?

SR

Susan Redline

Principal Investigator

Brigham and Women's Hospital

RA

Raouf Amin

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children and teens aged 5 to 17.9 with Down Syndrome who have moderate to severe Obstructive Sleep Apnea (OSA). They should be able to perform neuropsychological tests, not use CPAP regularly or take supplemental oxygen, and must not have other severe chronic diseases or untreated hypothyroidism.

Inclusion Criteria

My child has moderate to severe sleep apnea.
At baseline, the participant attempts to perform the neuropsychological tests
I am willing and able to follow all study rules and attend all appointments.
See 4 more

Exclusion Criteria

You currently use a CPAP machine for sleep apnea and use it for at least 4 hours every night.
Your oxygen level is less than 90% when you are awake and not active.
Someone smokes in the child's bedroom.
See 9 more

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

Baseline data collection including demographic data, neurocognitive testing, echocardiography, physical examination, and venipuncture

1-2 weeks
1 visit (in-person)

Treatment

Participants receive nocturnal oxygen therapy and supportive care materials for 6 months

6 months
2 visits (in-person), 1 visit (virtual) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat of baseline studies and PSG

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Oxygen
Trial Overview The study is testing if giving extra oxygen during sleep can help improve working memory and other outcomes in kids with Down Syndrome who also suffer from OSA. The oxygen flow won't exceed certain limits, ensuring safety.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Oxygen plus supportive care (OXT)Active Control1 Intervention
Group II: Supportive care (SC)Active Control1 Intervention

Oxygen is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Oxygen for:
🇪🇺
Approved in European Union as Oxygen for:
🇨🇦
Approved in Canada as Oxygen for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Rainbow Babies and Children's Hospital

Collaborator

Trials
9
Recruited
4,000+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials
844
Recruited
6,566,000+

Children's Hospital Los Angeles

Collaborator

Trials
257
Recruited
5,075,000+

Children's Hospital of The King's Daughters

Collaborator

Trials
14
Recruited
12,000+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Published Research Related to This Trial

In a study of 18,181 patients with Down syndrome, those aged 6 and older had significantly higher odds of developing Obstructive Sleep Apnea (OSA), with odds ratios ranging from 3.4 to 3.6 compared to younger patients.
Hypertrophied tonsils and adenoids were identified as the strongest risk factors for OSA, with an odds ratio of 64.2 when both conditions were present, highlighting the importance of monitoring these conditions in Down syndrome patients.
What are the Soft Tissue Risk Factors for Obstructive Sleep Apnea in Patients with Down's Syndrome?Stanbouly, D., Steinberg, B., Chuang, SK.[2023]
In a study of 16 children aged 2-8 with obstructive sleep apnea syndrome (OSAS), supplemental oxygen significantly improved oxygen levels during sleep, raising average SpO2 from 89.5% to 97.7%.
The use of supplemental oxygen also led to a reduction in hypopnea density and obstructive apnea index, while maintaining stable ventilation, suggesting it may be a safe and effective temporary treatment for children with OSAS.
Effects of overnight supplemental oxygen in obstructive sleep apnea in children.Aljadeff, G., Gozal, D., Bailey-Wahl, SL., et al.[2013]
A new aggressive surgical approach for treating obstructive sleep apnea in children with Down syndrome showed significant improvement, with the apnea index dropping from a mean of 34.00 preoperatively to 1.62 postoperatively, indicating effective management of the condition.
All seven children in the study experienced symptomatic improvement, although one patient faced complications leading to a tracheostomy, highlighting the need for careful preoperative evaluation, including cardiac assessments, in this vulnerable population.
Down syndrome: identification and surgical management of obstructive sleep apnea.Lefaivre, JF., Cohen, SR., Burstein, FD., et al.[2019]

Citations

What are the Soft Tissue Risk Factors for Obstructive Sleep Apnea in Patients with Down's Syndrome? [2023]
Effects of overnight supplemental oxygen in obstructive sleep apnea in children. [2013]
Down syndrome: identification and surgical management of obstructive sleep apnea. [2019]
Prospective polysomnographic analysis of obstructive sleep apnea in down syndrome. [2013]
Outcomes in children with down syndrome and mild obstructive sleep apnea treated non-surgically. [2021]
Long-term oxygen therapy in children with sickle cell disease and hypoxaemia. [2021]
The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome. [2023]
Obstructive sleep apnea and oxygen therapy: a systematic review of the literature and meta-analysis. [2021]
Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea. [2023]
Obstructive sleep apnea in patients with Down syndrome: current perspectives. [2020]
Feasibility and Long-Term Compliance to Continuous Positive Airway Pressure Treatment in Adults With Down Syndrome, a Genetic Form of Alzheimer's Disease. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Obstructive sleep apnea in Down syndrome: Benefits of surgery and noninvasive respiratory support. [2020]
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