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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• Ages 5.0 to 17.9 years at the time of screening

• Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.

• 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.

• Favorable response to oxygen therapy (allowing randomization) will be defined as follows:

‣ Oxygen saturation nadir \>92% and

⁃ Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG

⁃ 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.

⁃ Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.

• Willingness to comply with all study procedures and available for duration of study.

• At baseline the participant attempts to perform the neuropsychological tests

Locations
United States
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Michigan
University of Michigan, Ann Arbor Hospital
RECRUITING
Ann Arbor
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Rainbow Babies and Children's Hospital, Case Medical Center
RECRUITING
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Virginia
East Virginia Medical Center
RECRUITING
Norfolk
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Oltion Sina
osina@bwh.harvard.edu
8573407909
Backup
Suzie Hicks
suzanna.hicks@cchmc.org
5136364944
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 230
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Southern California, Seattle Children's Hospital, University of Michigan, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, Rainbow Babies and Children's Hospital, Children's Hospital of Philadelphia, Children's Hospital of The King's Daughters

This content was sourced from clinicaltrials.gov