Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea

Description

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).

Conditions

Down Syndrome, Obstructive Sleep Apnea

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Study Overview

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Study Details

Study overview

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).

Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea

Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea

Condition
Down Syndrome
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

Ann Arbor

University of Michigan, Ann Arbor Hospital, Ann Arbor, Michigan, United States, 48109

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Cleveland

Rainbow Babies and Children's Hospital, Case Medical Center, Cleveland, Ohio, United States, 44106

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Norfolk

East Virginia Medical Center, Norfolk, Virginia, United States, 23507

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ages 5.0 to 17.9 years at the time of screening
  • 2. Children with Obstructive Sleep Apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40/hour. :
  • 3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60%.
  • 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 oxygen flow, which is defined as the flow that achieves the lowest level of AHI without hypoventilation.
  • 4. Oxygen flow required does not exceed 3.0 liter/minute or Fraction of Inspired Oxygen (FiO2) \>40%.
  • 5. Willingness to comply with all study procedures and be available for the duration of study.
  • 6. At baseline, the participant attempts to perform the neuropsychological tests
  • 1. Current CPAP use with documented compliance(\> 4 hrs/ night; \> 70% of nights).
  • 2. Oxygen saturation \< 90% at rest during wakefulness.
  • 3. Chronic daytime or nighttime use of supplemental oxygen.
  • 4. Smoker in the child's bedroom.
  • 5. Unrepaired congenital heart disease.
  • 6. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
  • 7. Unable to participate in a PSG.
  • 8. Individuals who develop alveolar hypoventilation with oxygen as previously defined.
  • 9. Other severe chronic diseases determined by their provider as making them poor study candidates.
  • 10. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
  • 11. Documented clinically significant untreated hypothyroidism
  • 12. Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.

Ages Eligible for Study

5 Years to 215 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Susan Redline, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Raouf Amin, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2027-12-27