Down Syndrome Obstructive Sleep Apnea

NCT06043440 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023P000062
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (2)

• Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score

  Change from baseline in the Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (BRIEF2wm). The score ranges from 35-90. A higher score is a worse outcome.

  Baseline and 6 months

• Differential Ability Scales - 2nd Edition (DAS-II) T-score.

  Change from baseline in the Differential Ability Scales - 2nd Edition (DAS-II) recognition of pictures (DAS2RoP) T-score. The score ranges from 10-90. A higher score is a better outcome.

  Baseline and 6 months

Secondary Outcomes (40)

• Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score

  Baseline and 6 Months

• Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score

  Baseline and 6 Months

• Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score

  Baseline and 6 Months

• Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score

  Baseline and 6 Months

• Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed

  Baseline and 6 Months

Study Arms (2)

Oxygen plus supportive care (OXT)

ACTIVE COMPARATOR

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

Drug: Oxygen

Supportive care (SC)

NO INTERVENTION

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

Interventions

Oxygen DRUG

Active nocturnal oxygen concentrator

Oxygen plus supportive care (OXT)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current CPAP use with documented compliance(\> 4 hrs/ night; \> 70% of nights).
• Oxygen saturation \< 90% at rest during wakefulness.
• Chronic daytime or nighttime use of supplemental oxygen.
• Smoker in the child's bedroom.
• Unrepaired congenital heart disease.
• Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
• Unable to participate in a PSG.
• Individuals who develop alveolar hypoventilation with oxygen as previously defined.
• Other severe chronic diseases determined by their provider as making them poor study candidates.
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
• Documented clinically significant untreated hypothyroidism
• Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• Children's Hospital of Philadelphia: collaborator
• Rainbow Babies and Children's Hospital: collaborator
• University of Michigan: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's Hospital of The King's Daughters: collaborator
• Seattle Children's Hospital: collaborator
• University of Southern California: collaborator

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of Michigan, Ann Arbor Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Rainbow Babies and Children's Hospital, Case Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

East Virginia Medical Center

Norfolk, Virginia, 23507, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (58)

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MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Susan Redline

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Raouf Amin

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oltion Sina

CONTACT

8573407909; osina@bwh.harvard.edu

Suzie Hicks

CONTACT

5136364944; suzanna.hicks@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 21, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

US (7)