Obstructive ApneaDOSANCT06609694

Comparison of a Demand Oxygen Delivery

A study testing Portable oxygen concentrator Inogen G5 model in people with Obstructive Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site 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

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Trial summary

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los… Read more about this study

Who is it for?: Ages 5 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Obstructive Apnea
What is being tested?: Portable oxygen concentrator Inogen G5 model
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 9 Jan 2023to 1 Dec 2028
Phase: Interventional
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 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age 5-17 years with or without Down Syndrome (DS).
Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
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.

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.
Unable to participate in a Polysomnogram (PSG).
Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Trial locations and contacts

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

Suzie Hicks, BS contact

513-636-4944

suzie.hicks@cchmc.org

United States1 site, 1 recruiting

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Suzie Hicks, BS, 5136364944, suzie.hicks@cchmc.org
Raouf Amin, MD, rauof.amin@cchmc.org
Recruiting

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About this study

Official title: Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.

The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.

Read the detailed description

Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only. Pulse flow oxygen concentrators have been used clinically in adults. However, there is limited experience with this technology in children. The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data.

This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow. The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea, neurocognitive and cardiac outcomes. A separate Institutional Review Board (IRB) protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board.

Conditions: Obstructive Apnea
Being tested: Portable oxygen concentrator Inogen G5 model
Keywords: Sleep Apnea, Down Syndrome, Continuous Positive Airway Pressure (CPAP)
Medical subject headings: Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Down Syndrome

What participants receive

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

Portable oxygen concentrator Inogen G5 modelDevice
The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.

Study groups in NCT06609694
Study group	Role	What they receive
Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)	Experimental	The aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow. Receives: Device: Portable oxygen concentrator Inogen G5 model
Reducing the frequency of obstructive apnea (Main study)	Experimental	The arm of the main study is still under development Receives: Device: Portable oxygen concentrator Inogen G5 model

What is being measured

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

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour
Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or < 5 /hour
Measured: 6 months

Secondary outcomes (5)

Value of Oxygen Saturation (SpO2)
The total value of how much oxygen saturation happens while sleeping will be measured at baseline and 6 month visit.
Measured: 6 months
Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%
At the baseline and 6 month visit will measure the number of times that SpO2 falls below 90% will sleeping.
Measured: 6 months
Pulse Rate during sleep
Mean pulse rate during the total sleep time (beats per min) as well as the maximum pulse rate will be captured during sleep.
Measured: 6 months
Frequency of apnea happening during sleep
The total number of apnea events occurring per hour will be measured during sleep
Measured: 6 months
Total hours of Sleep Time
Total sleep time will be confirmed by an electroencephalogram (h)
Measured: 6 months

Timeline

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

9 Jan 20231 Dec 2028

First posted24 Sep 2024
Study start9 Jan 2023
Primary completion1 Dec 2027 (estimated)
Study completion1 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Obstructive ApneaStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Model description: The aim of this study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow. This aim will be accomplished by a randomized crossover study design.
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06609694
Sponsor's protocol ID: 2022-0821
Other IDs: R61HL165366
Acronym: DOSA
Status last verified: Jan 2026
First submitted: 6 Jan 2023
Last updated: 7 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The primary goal of this study is to assess feasibility of using pulse oxygen flow in children with Down syndrome and obstructive sleep apnea population. Preliminary data on the response rates from the two concentrators will be obtained and a confidence interval for the difference in response rate will be obtained. Data that is obtained from the devices will be shared with Inogen. Data will be deidentified prior to sending.

Publications

Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002 Jan 30;21(2):231-45. doi: 10.1002/sim.1012.
PubMed 11782062
Chamseddin BH, Johnson RF, Mitchell RB. Obstructive Sleep Apnea in Children with Down Syndrome: Demographic, Clinical, and Polysomnographic Features. Otolaryngol Head Neck Surg. 2019 Jan;160(1):150-157. doi: 10.1177/0194599818797308. Epub 2018 Aug 28.
PubMed 30149781
Lee CF, Lee CH, Hsueh WY, Lin MT, Kang KT. Prevalence of Obstructive Sleep Apnea in Children With Down Syndrome: A Meta-Analysis. J Clin Sleep Med. 2018 May 15;14(5):867-875. doi: 10.5664/jcsm.7126.
PubMed 29734982
Waters KA, Castro C, Chawla J. The spectrum of obstructive sleep apnea in infants and children with Down Syndrome. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109763. doi: 10.1016/j.ijporl.2019.109763. Epub 2019 Nov 1.
PubMed 31704574
Nerfeldt P, Sundelin A. Obstructive sleep apnea in children with down syndrome - Prevalence and evaluation of surgical treatment. Int J Pediatr Otorhinolaryngol. 2020 Jun;133:109968. doi: 10.1016/j.ijporl.2020.109968. Epub 2020 Feb 26.
PubMed 32126418
Shete MM, Stocks RM, Sebelik ME, Schoumacher RA. Effects of adeno-tonsillectomy on polysomnography patterns in Down syndrome children with obstructive sleep apnea: a comparative study with children without Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):241-4. doi: 10.1016/j.ijporl.2009.11.006. Epub 2010 Jan 25.
PubMed 20097432
MacDonagh L, Farrell L, O'Reilly R, McNally P, Javadpour S, Cox DW. Efficacy and adherence of noninvasive ventilation treatment in children with Down syndrome. Pediatr Pulmonol. 2021 Jun;56(6):1704-1715. doi: 10.1002/ppul.25308. Epub 2021 Mar 17.
PubMed 33730448
Trucco F, Chatwin M, Semple T, Rosenthal M, Bush A, Tan HL. Sleep disordered breathing and ventilatory support in children with Down syndrome. Pediatr Pulmonol. 2018 Oct;53(10):1414-1421. doi: 10.1002/ppul.24122. Epub 2018 Jul 10.
PubMed 29992744
Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020.
PubMed 33194886
Dudoignon B, Amaddeo A, Frapin A, Thierry B, de Sanctis L, Arroyo JO, Khirani S, Fauroux B. Obstructive sleep apnea in Down syndrome: Benefits of surgery and noninvasive respiratory support. Am J Med Genet A. 2017 Aug;173(8):2074-2080. doi: 10.1002/ajmg.a.38283. Epub 2017 May 24.
PubMed 28544488

Interested in taking part?

Suzie Hicks, BS

513-636-4944

suzie.hicks@cchmc.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Obstructive Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep
ClinicalTrials.gov ID: NCT06609694
Acronym / sponsor ID: DOSA / 2022-0821
Conditions: Obstructive Apnea
Keywords: Sleep Apnea, Down Syndrome, Continuous Positive Airway Pressure (CPAP)
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 9 Jan 2023 (actual)
Primary completion: 1 Dec 2027 (estimated)
Study completion: 1 Dec 2028 (estimated)
First posted: 24 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: The aim of this study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow. This aim will be accomplished by a randomized crossover study design.

Arm	Type	Receives
Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)	Experimental	Device: Portable oxygen concentrator Inogen G5 modelThe aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow.
Reducing the frequency of obstructive apnea (Main study)	Experimental	Device: Portable oxygen concentrator Inogen G5 modelThe arm of the main study is still under development

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Age 5-17 years with or without Down Syndrome (DS).
Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
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.

Key exclusion criteria (5 listed)

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.
Unable to participate in a Polysomnogram (PSG).
Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Portable oxygen concentrator Inogen G5 modelThe concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.	Device	Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study), Reducing the frequency of obstructive apnea (Main study)

Primary outcome

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour
Time frame: 6 months
Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or < 5 /hour

5 secondary outcomes

Value of Oxygen Saturation (SpO2)
Time frame: 6 months
Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%
Time frame: 6 months
Pulse Rate during sleep
Time frame: 6 months
Frequency of apnea happening during sleep
Time frame: 6 months
Total hours of Sleep Time
Time frame: 6 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Background: PubMed 11782062Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002 Jan 30;21(2):231-45. doi: 10.1002/sim.1012.
Results publication: PubMed 30149781Chamseddin BH, Johnson RF, Mitchell RB. Obstructive Sleep Apnea in Children with Down Syndrome: Demographic, Clinical, and Polysomnographic Features. Otolaryngol Head Neck Surg. 2019 Jan;160(1):150-157. doi: 10.1177/0194599818797308. Epub 2018 Aug 28.
Results publication: PubMed 29734982Lee CF, Lee CH, Hsueh WY, Lin MT, Kang KT. Prevalence of Obstructive Sleep Apnea in Children With Down Syndrome: A Meta-Analysis. J Clin Sleep Med. 2018 May 15;14(5):867-875. doi: 10.5664/jcsm.7126.
Results publication: PubMed 31704574Waters KA, Castro C, Chawla J. The spectrum of obstructive sleep apnea in infants and children with Down Syndrome. Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109763. doi: 10.1016/j.ijporl.2019.109763. Epub 2019 Nov 1.
Results publication: PubMed 32126418Nerfeldt P, Sundelin A. Obstructive sleep apnea in children with down syndrome - Prevalence and evaluation of surgical treatment. Int J Pediatr Otorhinolaryngol. 2020 Jun;133:109968. doi: 10.1016/j.ijporl.2020.109968. Epub 2020 Feb 26.
Results publication: PubMed 20097432Shete MM, Stocks RM, Sebelik ME, Schoumacher RA. Effects of adeno-tonsillectomy on polysomnography patterns in Down syndrome children with obstructive sleep apnea: a comparative study with children without Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):241-4. doi: 10.1016/j.ijporl.2009.11.006. Epub 2010 Jan 25.
Results publication: PubMed 33730448MacDonagh L, Farrell L, O'Reilly R, McNally P, Javadpour S, Cox DW. Efficacy and adherence of noninvasive ventilation treatment in children with Down syndrome. Pediatr Pulmonol. 2021 Jun;56(6):1704-1715. doi: 10.1002/ppul.25308. Epub 2021 Mar 17.
Results publication: PubMed 29992744Trucco F, Chatwin M, Semple T, Rosenthal M, Bush A, Tan HL. Sleep disordered breathing and ventilatory support in children with Down syndrome. Pediatr Pulmonol. 2018 Oct;53(10):1414-1421. doi: 10.1002/ppul.24122. Epub 2018 Jul 10.
Results publication: PubMed 33194886Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020.
Results publication: PubMed 28544488Dudoignon B, Amaddeo A, Frapin A, Thierry B, de Sanctis L, Arroyo JO, Khirani S, Fauroux B. Obstructive sleep apnea in Down syndrome: Benefits of surgery and noninvasive respiratory support. Am J Med Genet A. 2017 Aug;173(8):2074-2080. doi: 10.1002/ajmg.a.38283. Epub 2017 May 24.
Individual participant dataSharing planned: Yes. The primary goal of this study is to assess feasibility of using pulse oxygen flow in children with Down syndrome and obstructive sleep apnea population. Preliminary data on the response rates from the two concentrators will be obtained and a confidence interval for the difference in response rate will be obtained. Data that is obtained from the devices will be shared with Inogen. Data will be deidentified prior to sending.

Related trials for Obstructive Apnea

Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
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Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Suzie Hicks, BS contact

513-636-4944

suzie.hicks@cchmc.org

Raouf Amin, MD principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Portable oxygen concentrator Inogen G5 model in people with Obstructive Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 3 inclusion and 5 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 Suzie Hicks, BS (513-636-4944, suzie.hicks@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour (time frame: 6 months). 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 NCT06609694, which also lists 10 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 7 Jan 2026.