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RecruitingNCT06043440DOSAUpdated Sep 30, 2026

Down Syndrome Obstructive Sleep Apnea

A Phase 2 interventional study of Oxygen in Down Syndrome and Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital. Recruiting at 7 sites in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Updated Sep 30, 2026Sponsor changedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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).

Read the detailed description

This will be a randomized, single-blind 6-month Phase-2 clinical trial that compares the impact of oxygen therapy during sleep on measures of cognition, behavior, quality of life, cardiac structure and function, and sleep in children with Down Syndrome(DS) with moderate to severe obstructive sleep apnea.

The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations.

Children who agree to participate in the study will be screened for eligibility based on history, physical examination, and review of medical records including history of congenital heart disease and Pulmonary Hypertension (PHTN), and use of Continuous Positive Airway Pressure (CPAP). Children eligible for the study are those with persistent obstructive apnea after adenotonsillectomy or children with obstructive sleep apnea without adenotonsillar hypertrophy or in situations when parents refuse adenotonsillectomy.. The enrollment PSG eligibility will be determined by central scoring of either a research Polysomnography (PSG). In addition to an oxygen titration PSG, which determines responsiveness to oxygen, participants will be asked to wear a wrist actigraph and undergo neurocognitive testing, echocardiography, physical examination, anthropometry, and venipuncture. Caregivers will complete questionnaires to assess their child's emotional, physical, social, and school functioning, sleep quality; child's behavior and cognitive function, and will complete a sleep diary that is used concurrently with their child's use of a wrist actigraph. The latter includes caregiver completion of the "Behavior Rating Inventory of Executive Function" (BRIEF2), a co-primary outcome.

At 3 months, caregivers will complete the BRIEF2. At 6 months, all baseline studies and a PSG will be repeated.

At baseline, demographic data will be collected, including information on residential address (for use in geocoding).

02

Conditions studied

  • Down Syndrome
  • Obstructive Sleep Apnea
03

In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 230 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Browse Brigham and Women's Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 untreated hypothyroidism
  12. Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
230 participants (estimated)

Study 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.

    Drug: Oxygen

  • No intervention
    Supportive care (SC)

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

Interventions

  • DrugOxygen

    Active nocturnal oxygen concentrator

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 months

  2. 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.

    Time frame: Baseline and 6 months

Secondary outcomes

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

    Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Total raw score. The score ranges from 0-64. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

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

    Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Verbal raw score. The score ranges from 0-30. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

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

    Change from baseline of Stanford-Binet Intelligence Scales, 5th edition (SB-5) Working Memory Non Verbal raw score. The score ranges from 0-34. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

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

    Change from baseline in Differential Ability Scales-2 (DAS-II) Recall of Digits Forward raw score. The score ranges from 0-38. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

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

    Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) adjusted total errors based on stages completed

    Time frame: Baseline and 6 Months

  6. Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)

    Change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time (RTI)

    Time frame: Baseline and 6 Months

  7. Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score

    Change from baseline in Developmental Neuropsychological Assessment 2nd Edition (NEPSY-II) verbal fluency test raw score. Range-N/A

    Time frame: Baseline and 6 Months

  8. Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score

    Change from baseline in Observer Memory Questionnaire - Parent Form (OMQ-PF) total T-score. The score ranges from 0-135. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

  9. Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate)

    Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate).

    Time frame: Baseline and 6 Months

  10. Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).

    Change from baseline in Child Behavior Checklist (CBCL) T-scores for domains (Internalizing, Externalizing, Total Problems).

    Time frame: Baseline and 6 Months

  11. Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)

    Change from baseline in Child Behavior Checklist (CBCL) T-scores for subscales (Attention Problems, Thought Problems, Rule-Breaking Behaviors, Aggressive Behaviors)

    Time frame: Baseline and 6 Months

  12. KIDSCREEN-27 T-score

    Change from baseline in KIDSCREEN-27 T-score, including domains of: physical well-being; psychological well-being; autonomy and parent relations; social support and peers; school environment. Range-N/A

    Time frame: Baseline and 6 Months

  13. Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score

    Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance T-score. The score ranges from 28.7-85.6. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  14. Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score

    Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score. The score ranges from 37.9-86.6. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  15. Presence of right ventricular hypertension

    Presence of right ventricular hypertension as measured by tricuspid regurgitation continuous wave peak velocity (defined as a ratio of pulmonary artery pressure / systolic arterial pressure (PAP/SAP) \>1/3); interventricular septal flattening as measured by eccentricity index (defined as systolic ratio of \>1.25)

    Time frame: Baseline and 6 Months

  16. Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score

    Change from baseline of Wechsler Intelligence Scale (WISC) for Children 5th edition (WISC-5) Cancellation raw score. The score ranges from 0-128. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

  17. Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score

    Change from baseline in Wechsler Preschool and Primary Scale of Intelligence 4th edition (WPPSI-4) Cancellation task raw score (if unable to complete Wechsler Intelligence Scale 5th edition Cancellation test). The score ranges from 0-96. A higher score is a better outcome.

    Time frame: Baseline and 6 Months

  18. Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain.

    Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Behavior Regulation Index (BRI) domain. The score ranges from 35-90. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  19. Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain.

    Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Emotional Recognition Index (ERI) domain. The score ranges from 35-90. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  20. Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain.

    Change from baseline in Behavior Rating Inventory of Executive Function 2 (BRIEF2) T-scores for Cognitive Regulation Index (CRI) domain. The score ranges from 35-90. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  21. 7-day actigraphy measurement of sleep efficiency

    Change from baseline in 7-day actigraphy measurement of sleep efficiency

    Time frame: Baseline and 6 Months

  22. 7-day actigraphy measurement of time wake after sleep onset

    Change from baseline in 7-day actigraphy measurement of time wake after sleep onset

    Time frame: Baseline and 6 Months

  23. 7-day actigraphy measurement of sleep fragmentation

    Change from baseline in 7-day actigraphy measurement of sleep fragmentation

    Time frame: Baseline and 6 Months

  24. 7-day actigraphy measurement of total sleep duration

    Change from baseline in 7-day actigraphy measurement of total sleep duration

    Time frame: Baseline and 6 Months

  25. Polysomnography (PSG) AHI parameter

    Change from baseline in Polysomnography (PSG) AHI parameter. The score ranges from 0- \>40. A higher score is a worse outcome.

    Time frame: Baseline and 6 Months

  26. Polysomnography (PSG) percentage time of O2 <90 % parameter

    Change from baseline in Polysomnography (PSG) percentage time of O2 \<90 % parameter

    Time frame: Baseline and 6 Months

  27. Polysomnography (PSG) sleep apnea associated hypoxic burden parameter

    Change from baseline in Polysomnography (PSG) sleep apnea associated hypoxic burden, parameter

    Time frame: Baseline and 6 Months

  28. Polysomnography (PSG) end-tidal CO2 level, parameter

    Change from baseline in Polysomnography (PSG) end-tidal CO2 parameter.

    Time frame: Baseline and 6 Months

  29. Polysomnography (PSG) -based measure of sleep stages

    Change from baseline in Polysomnography (PSG) -based measure of sleep stages. Range- N/A

    Time frame: Baseline and 6 Months

  30. Polysomnography (PSG) -based measure of EEG power bands

    Change from baseline in Polysomnography (PSG) -based measure of EEG power bands

    Time frame: Baseline and 6 Months

  31. Polysomnography (PSG) -based measure of spindle morphology

    Change from baseline in Polysomnography (PSG) -based measure of spindle morphology

    Time frame: Baseline and 6 Months

  32. Polysomnography (PSG) -based measure of spindle numbers

    Change from baseline in Polysomnography (PSG) -based measure of spindle numbers

    Time frame: Baseline and 6 Months

  33. Polysomnography (PSG) -based measure of spindle density

    Change from baseline in Polysomnography (PSG) -based measure of spindle density

    Time frame: Baseline and 6 Months

  34. Polysomnography (PSG) -based measure of slow wave oscillations

    Change from baseline in Polysomnography (PSG) -based measure of slow wave oscillations

    Time frame: Baseline and 6 Months

  35. Left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)

    Change from baseline in left ventricular diastolic function as measured by Mitral E and A wave (E:A ratio)

    Time frame: Baseline and 6 Months

  36. Left ventricular diastolic function as measured by E wave deceleration time

    Change from baseline in left ventricular diastolic function as measured by E wave deceleration time

    Time frame: Baseline and 6 Months

  37. Left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')

    Change from baseline in left ventricular diastolic function as measured by Mitral septal and lateral e' and a' (E/e')

    Time frame: Baseline and 6 Months

  38. Left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time

    Change from baseline in left ventricular diastolic function as measured by Mitral lateral tissue Doppler isovolumic relaxation time

    Time frame: Baseline and 6 Months

  39. Left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration

    Change from baseline in left ventricular diastolic function as measured by Pulmonary vein A wave reversal duration

    Time frame: Baseline and 6 Months

  40. Left ventricular diastolic function as measured by Left atrial volume

    Change from baseline in left ventricular diastolic function as measured by Left atrial volume

    Time frame: Baseline and 6 Months

07

Study locations

7 of 7 sites recruiting
08

References and documents

Publications

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  • Gimenez S, Videla L, Romero S, Benejam B, Clos S, Fernandez S, Martinez M, Carmona-Iragui M, Antonijoan RM, Mayos M, Fortuna A, Penacoba P, Plaza V, Osorio RS, Sharma RA, Bardes I, Rebillat AS, Lleo A, Blesa R, Videla S, Fortea J. Prevalence of Sleep Disorders in Adults With Down Syndrome: A Comparative Study of Self-Reported, Actigraphic, and Polysomnographic Findings. J Clin Sleep Med. 2018 Oct 15;14(10):1725-1733. doi: 10.5664/jcsm.7382. PubMed 30353801 ↗
  • Gimenez S, Altuna M, Blessing E, Osorio RM, Fortea J. Sleep Disorders in Adults with Down Syndrome. J Clin Med. 2021 Jul 6;10(14):3012. doi: 10.3390/jcm10143012. PubMed 34300177 ↗
  • Tarasiuk A, Greenberg-Dotan S, Simon-Tuval T, Freidman B, Goldbart AD, Tal A, Reuveni H. Elevated morbidity and health care use in children with obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2007 Jan 1;175(1):55-61. doi: 10.1164/rccm.200604-577OC. Epub 2006 Oct 12. PubMed 17038661 ↗
  • Reuveni H, Simon T, Tal A, Elhayany A, Tarasiuk A. Health care services utilization in children with obstructive sleep apnea syndrome. Pediatrics. 2002 Jul;110(1 Pt 1):68-72. doi: 10.1542/peds.110.1.68. PubMed 12093948 ↗
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  • Bergeron M, Duggins AL, Cohen AP, Leader BA, Ishman SL. The impact of persistent pediatric obstructive sleep apnea on the Quality of Life of Patients' families. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109723. doi: 10.1016/j.ijporl.2019.109723. Epub 2019 Oct 12. PubMed 31678898 ↗
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09

Updates

1 registry update since Sep 25, 2026
Sponsor
Collaborators added: Boston Children's Hospital
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Sponsor Collaborators added: Boston Children's Hospital
    + 3 other changes: verification date, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06043440
Lead sponsor
Brigham and Women's Hospital
Collaborators
Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Rainbow Babies and Children's Hospital, University of Michigan, Children's Hospital Los Angeles, Children's Hospital of The King's Daughters, Seattle Children's Hospital, University of Southern California, Boston Children's Hospital
Responsible party
Susan Redline (Proffesor, Brigham and Women's Hospital) — Principal investigator
First posted
Sep 21, 2023
Start date
Oct 24, 2023
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Oltion Sina
Contact
osina@bwh.harvard.edu
8573407909
Suzie Hicks
Contact
suzanna.hicks@cchmc.org
5136364944
Susan Redline
principal investigator · Brigham and Women's Hospital
Raouf Amin
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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