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Down SyndromePhase 2DOSANCT06043440

Down Syndrome Obstructive Sleep Apnea

A Phase 2 study testing Oxygen in people with Down Syndrome and Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Down Syndrome, Obstructive Sleep Apnea
What is being tested?
Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
7 sitesUnited States
Study dates
24 Oct 2023to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oltion Sina contact

8573407909

osina@bwh.harvard.edu

Suzie Hicks contact

5136364944

suzanna.hicks@cchmc.org

7 sites in 1 country

United States7 sites, 7 recruiting

  • University of Michigan, Ann Arbor Hospital

    Ann Arbor, Michigan, 48109

    Emily Herreshoff, egalopin@med.umich.edu

    Ronald Chervin, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Suzanna Hicks, suzanna.hicks@cchmc.org

    Raouf Amin, MD

    Recruiting

  • Rainbow Babies and Children's Hospital, Case Medical Center

    Cleveland, Ohio, 44106

    Alyssa Keller, Alyssa.Keller@Uhhospitals.org

    Sally Ibrahim, MD

    Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

    Danny Del Cid-Linare, ddelcidlinares@chla.usc.edu

    Sally Ward, MD

    Recruiting

  • East Virginia Medical Center

    Norfolk, Virginia, 23507

    Thomas Boswick, BoswicST@EVMS.edu

    Cristina Baldassari, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Ebereh Uwah, uwahe@chop.edu

    Christopher Cielo, MD

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Sharon McNamara, sharon.mcnamara@seattlechildrens.org

    Maida Chen, MD

    Recruiting

Other trials in United States

About this study

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

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).

Being tested
Oxygen
Medical subject headings
Down Syndrome, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    Active nocturnal oxygen concentrator

Study groups in NCT06043440
Study groupRoleWhat they receive
Oxygen plus supportive care (OXT)Active comparatorNocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Receives: Drug: Oxygen
Supportive care (SC)No interventionProviding patient with healthy sleep habits materials, healthy diet materials and nasal dilators.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline and 6 months

Secondary outcomes (40)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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)

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 6 Months

  21. 7-day actigraphy measurement of sleep efficiency

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

    Measured: 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

    Measured: Baseline and 6 Months

  23. 7-day actigraphy measurement of sleep fragmentation

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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: Baseline and 6 Months

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

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

    Measured: 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

    Measured: 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

    Measured: Baseline and 6 Months

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

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

    Measured: Baseline and 6 Months

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

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

    Measured: Baseline and 6 Months

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

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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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')

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline and 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start24 Oct 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06043440
Sponsor's protocol ID
2023P000062
Acronym
DOSA
Status last verified
Sep 2026
First submitted
17 Aug 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Das D, Medina B, Baktir MA, Mojabi FS, Fahimi A, Ponnusamy R, Salehi A. Increased incidence of intermittent hypoxemia in the Ts65Dn mouse model of Down syndrome. Neurosci Lett. 2015 Sep 14;604:91-6. doi: 10.1016/j.neulet.2015.07.040. Epub 2015 Aug 1.

    PubMed 26240993

  • Schloo BL, Vawter GF, Reid LM. Down syndrome: patterns of disturbed lung growth. Hum Pathol. 1991 Sep;22(9):919-23. doi: 10.1016/0046-8177(91)90183-p.

    PubMed 1833304

  • Bush D, Galambos C, Ivy DD, Abman SH, Wolter-Warmerdam K, Hickey F. Clinical Characteristics and Risk Factors for Developing Pulmonary Hypertension in Children with Down Syndrome. J Pediatr. 2018 Nov;202:212-219.e2. doi: 10.1016/j.jpeds.2018.06.031. Epub 2018 Jul 17.

    PubMed 30025669

  • Cooney TP, Wentworth PJ, Thurlbeck WM. Diminished radial count is found only postnatally in Down's syndrome. Pediatr Pulmonol. 1988;5(4):204-9. doi: 10.1002/ppul.1950050405.

    PubMed 2976929

  • Gonzalez OR, Gomez IG, Recalde AL, Landing BH. Postnatal development of the cystic lung lesion of Down syndrome: suggestion that the cause is reduced formation of peripheral air spaces. Pediatr Pathol. 1991 Jul-Aug;11(4):623-33. doi: 10.3109/15513819109064794.

    PubMed 1835001

  • O'Neill AC, Richter GT. Pharyngeal dysphagia in children with Down syndrome. Otolaryngol Head Neck Surg. 2013 Jul;149(1):146-50. doi: 10.1177/0194599813483445. Epub 2013 Mar 22.

    PubMed 23525851

  • Jackson A, Maybee J, Moran MK, Wolter-Warmerdam K, Hickey F. Clinical Characteristics of Dysphagia in Children with Down Syndrome. Dysphagia. 2016 Oct;31(5):663-71. doi: 10.1007/s00455-016-9725-7. Epub 2016 Jul 12.

    PubMed 27405422

  • Khoo MCK, Hu WH, Amin R. Effects of Ventilation-Perfusion Mismatch on Severity of Obstructive Sleep Apnea: A Modeling Study. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:2792-2795. doi: 10.1109/EMBC44109.2020.9175297.

    PubMed 33018586

  • Alex RM, Panza GS, Hakim H, Badr MS, Edwards BA, Sands SA, Mateika JH. Exposure to mild intermittent hypoxia increases loop gain and the arousal threshold in participants with obstructive sleep apnoea. J Physiol. 2019 Jul;597(14):3697-3711. doi: 10.1113/JP277711. Epub 2019 May 9.

    PubMed 31026056

  • Vetrano DL, Carfi A, Brandi V, L'Angiocola PD, Di Tella S, Cipriani MC, Antocicco M, Zuccala G, Palmieri V, Silveri MC, Bernabei R, Onder G. Left ventricle diastolic function and cognitive performance in adults with Down syndrome. Int J Cardiol. 2016 Jan 15;203:816-8. doi: 10.1016/j.ijcard.2015.11.041. Epub 2015 Nov 6. No abstract available.

    PubMed 26595792

  • Mann DM, Esiri MM. The pattern of acquisition of plaques and tangles in the brains of patients under 50 years of age with Down's syndrome. J Neurol Sci. 1989 Feb;89(2-3):169-79. doi: 10.1016/0022-510x(89)90019-1.

    PubMed 2522541

  • Bauer J, Strauss S, Schreiter-Gasser U, Ganter U, Schlegel P, Witt I, Yolk B, Berger M. Interleukin-6 and alpha-2-macroglobulin indicate an acute-phase state in Alzheimer's disease cortices. FEBS Lett. 1991 Jul 8;285(1):111-4. doi: 10.1016/0014-5793(91)80737-n.

    PubMed 1712317

  • Di Domenico F, Tramutola A, Butterfield DA. Role of 4-hydroxy-2-nonenal (HNE) in the pathogenesis of alzheimer disease and other selected age-related neurodegenerative disorders. Free Radic Biol Med. 2017 Oct;111:253-261. doi: 10.1016/j.freeradbiomed.2016.10.490. Epub 2016 Oct 24.

    PubMed 27789292

  • Lyman M, Lloyd DG, Ji X, Vizcaychipi MP, Ma D. Neuroinflammation: the role and consequences. Neurosci Res. 2014 Feb;79:1-12. doi: 10.1016/j.neures.2013.10.004. Epub 2013 Oct 19.

    PubMed 24144733

  • Rueda N, Vidal V, Garcia-Cerro S, Narcis JO, Llorens-Martin M, Corrales A, Lantigua S, Iglesias M, Merino J, Merino R, Martinez-Cue C. Anti-IL17 treatment ameliorates Down syndrome phenotypes in mice. Brain Behav Immun. 2018 Oct;73:235-251. doi: 10.1016/j.bbi.2018.05.008. Epub 2018 May 31.

    PubMed 29758264

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxygen in people with Down Syndrome and Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oltion Sina (8573407909, osina@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06043440, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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