Increased incidence of intermittent hypoxemia in the Ts65Dn mouse model of Down syndrome.
Devsmita Das, Brian Medina, Mehmet Akif Baktir...
https://pubmed.ncbi.nlm.nih.gov/26240993Actively Recruiting
Phase 2
Age: 5Years - 18Years
All Genders
ID06043440
Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
Led by Brigham and Women's Hospital · Updated on 2025-04-20
230
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
C
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether oxygen supplementation during sleep can improve working memory and other related clinical and patient-reported outcomes in children with Down Syndrome who have moderate to severe Obstructive Sleep Apnea (OSA). This randomized, single-blind Phase 2 clinical trial aims to compare the effects of oxygen therapy on cognition, behavior, quality of life, heart structure and function, and sleep patterns in this group. Children participating in the study will be randomly assigned to one of two groups: one receiving nocturnal oxygen therapy along with materials on healthy sleep habits, diet, and nasal dilators, and the other receiving only the supportive care materials without oxygen therapy. The study includes an initial screening with polysomnography (PSG) tests to assess sleep apnea severity and responsiveness to oxygen. Assessments will be repeated after 3 and 6 months, including a follow-up PSG and neurocognitive testing. During the study, children and their caregivers will take part in various evaluations such as wrist actigraphy to monitor sleep, echocardiography to examine heart function, neuropsychological tests, physical exams, and blood draws. Caregivers will complete questionnaires about the child's emotional, physical, social, and school functioning, as well as sleep quality and behavior. The primary outcomes include executive function working memory scores measured at the start and end of the 6-month period. The total participation duration is 6 months, with careful monitoring of sleep and cognitive changes throughout.
CONDITIONS
Brief Title
Down Syndrome Obstructive Sleep Apnea
Who Can Participate
Age: 5Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 5.0 to 17.9 years at the time of screening
- Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) of 5 or more per hour
- No clinically significant low oxygen levels defined as oxygen saturation below 88% for 5 minutes or episodic desaturation to 60%
- Favorable response to oxygen therapy defined by specific oxygen saturation and apnea index criteria during sleep study
- Oxygen flow required does not exceed 3.0 liters per minute and fraction of inspired oxygen is less than or equal to 40%
- Willingness to comply with all study procedures and available for the duration of the study
- Participant attempts to perform neuropsychological tests at baseline
You will not qualify if you...
- Current use of CPAP with documented compliance greater than 4 hours per night on more than 70% of nights
- Oxygen saturation less than 90% at rest while awake
- Chronic daytime or nighttime use of supplemental oxygen
- Smoker in the child's bedroom
- Unrepaired congenital heart disease
- Moderate to severe pulmonary hypertension requiring oxygen or pulmonary vasodilator treatment
- Unable to participate in a polysomnography (PSG) sleep study
- Development of alveolar hypoventilation with oxygen therapy
- Severe chronic diseases making the child a poor study candidate
- Enrolled or planning enrollment in conflicting clinical trials
- Clinically significant untreated hypothyroidism
- Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to surgery
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 6 months
Participants receive nocturnal oxygen therapy or supportive care for 6 months while undergoing assessments of cognition, behavior, quality of life, cardiac function, and sleep quality.
Baseline visit, 3-month follow-up visit, and 6-month final visit
Trial Site Locations
Total: 7 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of Michigan, Ann Arbor Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Rainbow Babies and Children's Hospital, Case Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
East Virginia Medical Center
Norfolk, Virginia, United States, 23507
Actively Recruiting
7
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
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Research Team
O
Oltion Sina
S
Suzie Hicks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Down syndrome: patterns of disturbed lung growth.
B L Schloo, G F Vawter, L M Reid
https://pubmed.ncbi.nlm.nih.gov/1833304Clinical Characteristics and Risk Factors for Developing Pulmonary Hypertension in Children with Down Syndrome.
Douglas Bush, Csaba Galambos, D Dunbar Ivy...
https://pubmed.ncbi.nlm.nih.gov/30025669Diminished radial count is found only postnatally in Down's syndrome.
T P Cooney, P J Wentworth, W M Thurlbeck
https://pubmed.ncbi.nlm.nih.gov/2976929Postnatal development of the cystic lung lesion of Down syndrome: suggestion that the cause is reduced formation of peripheral air spaces.
O R Gonzalez, I G Gomez, A L Recalde...
https://pubmed.ncbi.nlm.nih.gov/1835001Pharyngeal dysphagia in children with Down syndrome.
Ashley C O'Neill, Gresham T Richter
https://pubmed.ncbi.nlm.nih.gov/23525851Clinical Characteristics of Dysphagia in Children with Down Syndrome.
Arwen Jackson, Jennifer Maybee, Maura K Moran...
https://pubmed.ncbi.nlm.nih.gov/27405422Effects of Ventilation-Perfusion Mismatch on Severity of Obstructive Sleep Apnea: A Modeling Study.
Michael C K Khoo, Wen-Hsin Hu, Raouf Amin
https://pubmed.ncbi.nlm.nih.gov/33018586Exposure to mild intermittent hypoxia increases loop gain and the arousal threshold in participants with obstructive sleep apnoea.
Raichel M Alex, Gino S Panza, Huzaifa Hakim...
https://pubmed.ncbi.nlm.nih.gov/31026056Left ventricle diastolic function and cognitive performance in adults with Down syndrome.
Davide L Vetrano, Angelo Carfì, Vincenzo Brandi...
https://pubmed.ncbi.nlm.nih.gov/26595792