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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights

DOSA Trial 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.Check my eligibility
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.See study design
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.

DOSA Trial Eligibility Criteria

Inclusion Criteria

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

DOSA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Differential Ability Scales - 2nd Edition (DAS-II) T-score.
Secondary outcome measures
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

DOSA 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
906 Previous Clinical Trials
1,596,058 Total Patients Enrolled
University of MichiganOTHER
1,798 Previous Clinical Trials
6,377,908 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age restriction, and if so, what is the upper threshold?

"This trial is accepting participants who are between 5 years old and 17.5 years of age (or 215 months)."

Answered by AI

What is the status of OXT in terms of regulatory approval?

"Safety of Oxygen plus supportive care (OXT) was rated a 2 on the scale due to lack of evidence-based efficacy, but there is some clinical data supporting its safety."

Answered by AI

What is the extent of participation in this trial among healthcare facilities within the state?

"Currently, 7 medical centres are enrolling for this trial. Among these sites are Ann Arbor, Cincinnati and Cleveland as well as other nearby locations. To avoid excessive travelling it is recommended to choose the centre closest to you if one wishes to participate in the study."

Answered by AI

What criteria must be met to qualify for this research experiment?

"Patients that have down syndrome and are between 5-215 months old, can be accepted into this clinical trial of 230 participants."

Answered by AI

Are recruitment efforts still ongoing for this research project?

"According to the data available on clinicaltrials.gov, this trial has stopped recruiting and was last updated on September 12th 2023. However, there are still 1,750 other studies actively seeking patients at present."

Answered by AI

What outcome is this research endeavor hoping to accomplish?

"The main metric for evaluating the effectiveness of this trial are changes to a patient's Differential Ability Scales - 2nd Edition (DAS-II) working memory score over baseline and 6 month intervals. Secondary metrics include Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score, its change from baseline values, along with Stanford-Binet Intelligence Scales, 5th edition (SB-5) Non Verbal raw scores and their respective rate of variation as well as alterations in an individual's Differential Ability Scales-2 (DAS-II) Recall of Digits Forward"

Answered by AI

Who else is applying?

What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
Susan Redline 2023. "Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043440.
All > Apnea > Down Syndrome
~153 spots leftby Aug 2027
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