Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
Brigham and Women's Hospital
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) with moderate to severe Obstructive Sleep Apnea (OSA).
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 and function, and sleep in children with Down Syndrome(DS) with moderate to severe obstructive sleep apnea. The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations. Child…
Eligibility
- Age range
- 5–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ages 5.0 to 17.9 years at the time of screening 2. Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour. 3. 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. 4. Favorable response to oxygen therapy (allowing randomization) will be defined as follows: 1. Oxygen saturation nadir \>92% and 2. Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG 3. Reaching an optimum…
Interventions
- DrugOxygen
Active nocturnal oxygen concentrator
Locations (7)
- Children's Hospital of Los AngelesLos Angeles, California
- University of Michigan, Ann Arbor HospitalAnn Arbor, Michigan
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Rainbow Babies and Children's Hospital, Case Medical CenterCleveland, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- East Virginia Medical CenterNorfolk, Virginia