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Oxygen Therapy for Down Syndrome with Sleep Apnea (DOSA Trial)

Phase 2
Recruiting
Led By Susan Redline
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reaching an optimum oxygen flow, not exceeding 3.0 liter/minute or Fraction of Inspired Oxygen (FiO2) >40%
Favorable response to oxygen therapy defined as oxygen saturation nadir >92% and decrease in obstructive index < 5 / hour or by > 50% from screening PSG
Must not have
Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator
Unrepaired congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will see if oxygen during sleep can help kids with Down Syndrome and severe sleep apnea improve memory and other health outcomes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from wearing the oxygen delivery device and dry or irritated nasal passages due to the flow of oxygen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a low level of extra oxygen, not more than 3 liters per minute.
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My oxygen levels improved significantly with oxygen therapy.
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I am between 5 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need oxygen or medication to manage my severe lung blood pressure.
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I have a heart condition present since birth that hasn't been fixed.
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I use supplemental oxygen daily.
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I have trouble breathing deeply enough, even with oxygen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Differential Ability Scales - 2nd Edition (DAS-II) T-score.
Secondary study objectives
7-day actigraphy measurement of sleep efficiency
7-day actigraphy measurement of sleep fragmentation
7-day actigraphy measurement of time wake after sleep onset
+37 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Oxygen plus supportive care (OXT)Active Control1 Intervention
Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Group II: Supportive care (SC)Active Control1 Intervention
Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

Find a Location

Who is running the clinical trial?

Rainbow Babies and Children's HospitalOTHER
8 Previous Clinical Trials
3,723 Total Patients Enrolled
University of Southern CaliforniaOTHER
944 Previous Clinical Trials
1,604,415 Total Patients Enrolled
1 Trials studying Down Syndrome
450 Patients Enrolled for Down Syndrome
University of MichiganOTHER
1,852 Previous Clinical Trials
6,432,512 Total Patients Enrolled
6 Trials studying Down Syndrome
562 Patients Enrolled for Down Syndrome
~153 spots leftby Aug 2027
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