Down Syndrome Obstructive Sleep Apnea

Part of paid clinical trials in Los Angeles, California.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06043440
Phase
PHASE2
Status
Recruiting
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Conditions

  • Down Syndrome
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxygen — DRUG
    Active nocturnal oxygen concentrator

Study Details

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).

Key Dates

Start date
Oct 24, 2023
Status verified
Apr 2025
Primary completion
Nov 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Danny Del Cid-Linare
[email protected]
Sally Ward, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan, Ann Arbor HospitalAnn ArborMichigan48109
Emily Herreshoff
[email protected]
Ronald Chervin, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Suzanna Hicks
[email protected]
Raouf Amin, MD (PRINCIPAL_INVESTIGATOR)
Rainbow Babies and Children's Hospital, Case Medical CenterClevelandOhio44106
Alyssa Keller
[email protected]
Sally Ibrahim, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Christopher Cielo, MD (PRINCIPAL_INVESTIGATOR)
East Virginia Medical CenterNorfolkVirginia23507
Thomas Boswick
[email protected]
Cristina Baldassari, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Sharon McNamara
[email protected]
Maida Chen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CAUniversity of Michigan, Ann Arbor Hospital· Ann Arbor, MICincinnati Children's Hospital Medical Center· Cincinnati, OHRainbow Babies and Children's Hospital, Case Medical Center· Cleveland, OHChildren's Hospital of Philadelphia· Philadelphia, PAEast Virginia Medical Center· Norfolk, VA

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