BridgeMD
New treatment option for Down Syndrome
Official title Down Syndrome Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT06043440
What this study is testing
What is Oxygen?
Oxygen is an investigational medicine, being studied as a potential treatment for down syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- 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...
- Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
- Oxygen saturation nadir \>92% and
You likely can't join if
- 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.
- Unrepaired congenital heart disease.
- Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
See the full eligibility criteria
- 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.
- Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
- Oxygen saturation nadir \>92% and
- Decrease in obstructive index \ 50% from screening PSG
- Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15...
- Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.
- Willingness to comply with all study procedures and available for duration of study.
- At baseline the participant attempts to perform the neuropsychological tests
- 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.
- Unrepaired congenital heart disease.
- Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
- Unable to participate in a PSG.
- Individuals who develop alveolar hypoventilation with oxygen as previously defined.
- Other severe chronic diseases determined by their provider as making them poor study candidates.
- Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
- Documented clinically significant untreated hypothyroidism
- Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Ann Arbor, Michigan, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Norfolk, Virginia, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Ann Arbor, Michigan, United States; Cincinnati, Ohio, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Norfolk, Virginia, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.