What is oxygen therapy studying for children with Down Syndrome and Obstructive Sleep Apnea?

This trial is studying whether oxygen therapy during sleep can improve memory, behavior, quality of life, and heart function in children with Down Syndrome who have moderate to severe sleep apnea. The research aims to understand how oxygen affects cognition and sleep-related health. It is sponsored by Brigham and Women's Hospital.

Who may be eligible for this Down Syndrome clinical trial?

Children aged 5 to 17 years with moderate to severe obstructive sleep apnea may be eligible. Both boys and girls can participate. Children should not be currently using CPAP regularly or have unrepaired heart defects. Please review eligibility criteria for more details.

Is there any cost to participate in this Down Syndrome clinical trial?

Study-related care, including the study oxygen therapy and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively 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

Research Sites

4 weeks

Total Duration

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 childs 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

Research Team

Oltion Sina

Suzie Hicks

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here