Recruiting
Phase 2

Oxygen Therapy

Sponsor:

Brigham and Women's Hospital

Code:

NCT06043440

Conditions

Down Syndrome

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Oxygen

Study Details

Brief 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).

Conditions

Down Syndrome

Obstructive Sleep Apnea

Study ID

NCT06043440

Start date

Oct 24, 2023

Status verified date

Apr, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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 oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
4. Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 > 40 %.
5. Willingness to comply with all study procedures and available for duration of study.
6. At baseline the participant attempts to perform the neuropsychological tests

Exclusion Criteria:

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oxygen plus supportive care (OXT)

Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

no intervention: Supportive care (SC)

Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

Interventions

Oxygen

Active nocturnal oxygen concentrator

Primary outcome measure

  • Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score [ Time Frame: Baseline and 6 months ]
  • Differential Ability Scales - 2nd Edition (DAS-II) T-score. [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Locations

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Danny Del Cid-Linare

ddelcidlinares@chla.usc.edu

Principal Investigator:

Sally Ward, MD

University of Michigan, Ann Arbor Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Emily Herreshoff

egalopin@med.umich.edu

Principal Investigator:

Ronald Chervin, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Raouf Amin, MD

Rainbow Babies and Children's Hospital, Case Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Sally Ibrahim, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Ebereh Uwah

uwahe@chop.edu

Principal Investigator:

Christopher Cielo, MD

East Virginia Medical Center

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Thomas Boswick

BoswicST@EVMS.edu

Principal Investigator:

Cristina Baldassari, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Maida Chen, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 20, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-04-20.