RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-10-24

Study Completion:2027-12-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06043440

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.

Ages Eligible for Study:5 Years to 215 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Oltion Sina

CONTACT

8573407909

osina@bwh.harvard.edu

Suzie Hicks

CONTACT

5136364944

suzanna.hicks@cchmc.org

Principal Investigator

Susan Redline

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Raouf Amin

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Children's Hospital of Los Angeles

Los Angeles, California, 90027

United States

University of Michigan, Ann Arbor Hospital

Ann Arbor, Michigan, 48109

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Rainbow Babies and Children's Hospital, Case Medical Center

Cleveland, Ohio, 44106

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

East Virginia Medical Center

Norfolk, Virginia, 23507

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24

Study Completion Date2027-12-27

Study Record Updates

Study Start Date2023-10-24

Study Completion Date2027-12-27

Terms related to this study

Additional Relevant MeSH Terms

Down Syndrome
Obstructive Sleep Apnea