Status:
RECRUITING
Down Syndrome Obstructive Sleep Apnea
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Conditions:
Down Syndrome
Obstructive Sleep Apnea
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
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) w...
Detailed Description
This will be a randomized, single-blind 6-month Phase-2 clinical trial that compares the impact of oxygen therapy during sleep on measures of cognition, behavior, quality of life, cardiac structure an...
Eligibility Criteria
Inclusion
- 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 \< 5 / hour or by \> 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 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06043440
Start Date
October 24 2023
End Date
December 30 2027
Last Update
April 20 2025
Active Locations (7)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of Michigan, Ann Arbor Hospital
Ann Arbor, Michigan, United States, 48109
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
Rainbow Babies and Children's Hospital, Case Medical Center
Cleveland, Ohio, United States, 44106