Down Syndrome Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-18
SponsorBrigham and Women's Hospital
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 5.0 to 17.9 years at the time of screening
Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.
Absence of clinically significant hypoxia defined as oxygen saturation <88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
Oxygen saturation nadir >92% and
Disqualifiers
Current CPAP use with documented compliance(> 4 hrs/ night; > 70% of nights).
Oxygen saturation < 90% at rest during wakefulness.
Chronic daytime or nighttime use of supplemental oxygen.
Smoker in the child's bedroom.
Trial design
Design model
Parallel
Treatments tested in this trial
Oxygen
DrugActive nocturnal oxygen concentrator
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Oxygen plus supportive care (OXT)Active comparator 1 intervention
Group B: Supportive care (SC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Change from baseline in the Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (BRIEF2wm). The score ranges from 35-90. A higher score is a worse outcome.
Time frame
Baseline and 6 months2
Differential Ability Scales - 2nd Edition (DAS-II) T-score.
Change from baseline in the Differential Ability Scales - 2nd Edition (DAS-II) recognition of pictures (DAS2RoP) T-score. The score ranges from 10-90. A higher score is a better outcome.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score. The score ranges from 0-64. A higher score is a better outcome.
Time frame
Baseline and 6 Months2
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score. The score ranges from 0-30. A higher score is a better outcome.
Time frame
Baseline and 6 Months3
Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score
Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score. The score ranges from 0-34. A higher score is a better outcome.
Time frame
Baseline and 6 Months4
Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score
Change from baseline in Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score. The score ranges from 0-38. A higher score is a better outcome.
Time frame
Baseline and 6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborator
Children's Hospital of Philadelphia
Collaborator
Rainbow Babies and Children's Hospital
Collaborator
University of Michigan
Collaborator
Children's Hospital Los Angeles
Collaborator
Children's Hospital of The King's Daughters
Collaborator
Seattle Children's Hospital
Collaborator
University of Southern California
Collaborator
Boston Children's Hospital
Collaborator
Source ClinicalTrials.gov