Portable Oxygen Concentrator for Obstructive Sleep Apnea

(DOSA Trial)

Overseen By Suzie Hicks, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Current CPAP use, Oxygen saturation < 90%, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a portable oxygen concentrator to treat children with moderate to severe obstructive sleep apnea. Researchers compare two oxygen delivery methods during sleep to determine which is more effective: continuous flow and pulse flow (demand oxygen delivery). The trial includes children aged 5-17, with or without Down syndrome, who have sleep apnea but do not experience low oxygen levels during the day. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance sleep apnea treatments for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for children with Down syndrome?

Research has shown that portable oxygen concentrators, such as the Inogen unit, are often used for long-term oxygen therapy in individuals with breathing problems. However, specific safety information about their use for obstructive sleep apnea, particularly in children with Down syndrome, remains limited.

Portable oxygen concentrators are generally considered safe and are widely used. Studies indicate they can effectively complement other oxygen delivery methods. While this suggests general safety, detailed evidence for this specific use is lacking.

Since the trial examines a technology already in use, it is expected to be relatively safe. Participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a portable oxygen concentrator for obstructive sleep apnea because it offers a new way to deliver oxygen that's more convenient than traditional methods. Unlike standard treatments that use continuous flow oxygen, this device uses demand oxygen delivery, which means it only provides oxygen when you need it, potentially improving comfort and efficiency. This portable technology allows users more freedom and mobility, which could significantly enhance quality of life for individuals with obstructive sleep apnea.

What evidence suggests that this oxygen delivery method is effective for obstructive sleep apnea?

Research has shown that using a portable oxygen concentrator with an auto-demand function can improve oxygen levels during sleep and reduce breathing interruptions. This trial will compare the effectiveness of the Inogen portable oxygen concentrator unit with continuous flow oxygen delivery. Other studies have found that portable oxygen concentrators, such as the Inogen unit, effectively support respiratory health by delivering oxygen only when needed, making them more efficient than continuous flow. These devices maintain good oxygen levels without a constant flow, which benefits long-term use. ^{1 3 4 6 7}

Who Is on the Research Team?

Raouf Amin, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children with Down syndrome at Cincinnati Children's Hospital and Children's Hospital of Los Angeles who have moderate to severe obstructive sleep apnea. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact the study or their safety.

Inclusion Criteria

Absence of clinically significant hypoxia defined as oxygen saturation < 88% for 5 minutes or episodic desaturation to 60%

I am between 5 and 17 years old, with or without Down Syndrome.

My child has moderate to severe sleep apnea.

Exclusion Criteria

Unable to participate in a Polysomnogram (PSG)

I use supplemental oxygen daily.

Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxygen delivery through continuous flow and pulse flow during sleep, with 2 polysomnographies performed

6 months

2 visits (in-person) for polysomnographies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurocognitive and cardiac outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Demand Oxygen Delivery

Trial Overview The trial is testing a portable oxygen concentrator (Inogen G5 model) to treat obstructive sleep apnea in children with Down syndrome. It compares two methods of oxygen delivery during sleep: continuous flow versus pulse flow, using two separate polysomnographies.

How Is the Trial Designed?

Group I: Reducing the frequency of obstructive apnea (Main study) Experimental Treatment 1 Intervention

The arm of the main study is still under development

Group II: Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study) Experimental Treatment 1 Intervention

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.

Demand Oxygen Delivery is already approved in United States for the following indications:

Approved in United States as Oxygen Therapy for:

• Obstructive Sleep Apnea in Children with Down Syndrome

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 20 patients with chronic obstructive pulmonary disease or interstitial pneumonia is testing a new portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) to see if it is as effective as a continuous-flow oxygen concentrator for improving oxygen levels during sleep.

The primary goal is to measure mean oxygen saturation during sleep, and if the auto-DODS proves to be non-inferior, it could simplify treatment by allowing patients to use one device for both day and night oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia. Nagano, T., Kobayashi, K., Omori, T., et al.[2020]

Oxygen concentrators are reliable, convenient, and easy to use, making them a popular choice for delivering supplemental oxygen to home hospice patients.

While they are the most cost-effective option for healthcare institutions, the study highlights the need to analyze and address the operating costs of these devices from the patient's perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of breathing: an economic analysis of the patient cost of home oxygen therapy. Reisfield, GM., Wilson, GR.[2017]

A study analyzing 125 incident reports from four organizations found that 91% of the 272 incidents during the out-of-hospital transport of critically ill patients were preventable, highlighting significant safety concerns in this complex environment.

The most common contributing factors to these incidents included equipment issues (37%) and human errors (42%), with effective crew skills and teamwork being key factors in minimizing harm, suggesting that targeted training and equipment improvements could enhance patient safety during retrieval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidents during out-of-hospital patient transportation. Flabouris, A., Runciman, WB., Levings, B.[2019]

In a study of 490 pediatric emergency transports, airway management errors were common, with 21% of procedures related to oxygen use and 58% of intubations requiring three or more attempts or failing altogether.

The study highlighted that errors were particularly frequent during cardiac arrest situations, indicating a need for improved training and protocols in out-of-hospital airway management for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety events in out-of-hospital paediatric airway management: a medical record review by the CSI-EMS. Hansen, M., Meckler, G., Lambert, W., et al.[2018]

A total of 1085 airway-related safety incidents were reported in critical care units over two years, with 28.8% involving neonates or babies, highlighting a significant concern for this vulnerable population.

The study found that partial displacement of tracheal tubes led to more serious harm than complete displacement, and none of the incidents involved capnography, suggesting a need for improved monitoring and equipment standards to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety incidents associated with airway devices in critical care: a review of reports to the UK National Patient Safety Agency. Thomas, AN., McGrath, BA.[2022]

A patient using a portable oxygen concentrator during noninvasive ventilation (NIV) at night was found to have inadequate oxygen delivery and triggering capacity, regardless of the settings tested.

The study concluded that the portable oxygen concentrator should not be used during nocturnal NIV, highlighting potential safety concerns for patients with COPD and overlap syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable pulse-dose oxygen concentrators should not be used with noninvasive ventilation. Lobato, SD., Rodríguez, EP., Alises, SM.[2013]

Nocturnal oxygen therapy is not effective enough to be recommended as the only treatment for obstructive sleep apnea, indicating that additional therapies are necessary for effective management of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen for the treatment of obstructive sleep apnoea hypopnoea syndrome. Riha, RL.[2020]

The study tested four portable oxygen concentrator (POC) models and found significant differences in their oxygen delivery performance, with the Invacare XPO(2) providing the highest pulse flow and oxygen volume per pulse, while the AirSep FreeStyle delivered the lowest.

As respiratory rates increased, the relative fraction of inspired oxygen (F(IO(2))) decreased across all models, highlighting the importance of adjusting POC settings based on a patient's activity level to ensure adequate oxygen delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance comparison of 4 portable oxygen concentrators. Chatburn, RL., Williams, TJ.[2010]

A study involving 26 patients with chronic respiratory conditions will compare a new portable oxygen concentrator with auto-demand oxygen delivery system (auto-DODS) to a conventional system, focusing on its effectiveness in maintaining oxygen saturation during rest and exercise.

The primary goal is to assess mean oxygen saturation levels, while secondary measures will evaluate the device's operational efficiency, patient comfort, and overall reliability, providing insights into the potential benefits of the auto-DODS in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized cross-over trial of demand oxygen delivery system. Nagano, T., Kobayashi, K., Omori, T., et al.[2022]

In a study of 76 patients with obstructive sleep apnea, continuous positive airway pressure (CPAP) significantly improved sleep quality by increasing REM sleep and reducing light sleep, with effects noticeable from the first night of treatment.

CPAP also corrected respiratory issues and reduced arousal disturbances associated with OSA, while supplemental oxygen only improved oxygen saturation without enhancing overall sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure versus supplemental oxygen on sleep quality in obstructive sleep apnea: a placebo-CPAP-controlled study. Loredo, JS., Ancoli-Israel, S., Kim, EJ., et al.[2022]

In a trial with five male patients suffering from obstructive sleep apnoea (OSA), sleeping with 9% oxygen-enriched air significantly improved oxygen saturation levels and reduced the number of apnoea episodes, particularly the longer ones.

The study found no negative effects on the patients' ventilatory drive, suggesting that modest oxygen enrichment could be a safe and effective therapeutic option for managing OSA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal oxygen enrichment in sleep apnoea. Pokorski, M., Jernajczyk, U.[2017]

The Difficult Airway Response Team (DART) program at Johns Hopkins Hospital was established to systematically address airway-related emergencies, responding to around 1000 events without any resulting adverse outcomes or morbidity.

The program highlights the importance of a multidisciplinary approach and operational protocols in improving patient safety during difficult airway situations, providing valuable lessons for other institutions considering similar initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Decade of Difficult Airway Response Team: Lessons Learned from a Hospital-Wide Difficult Airway Response Team Program. Mark, L., Lester, L., Cover, R., et al.[2019]

A review of 7827 safety reports from 2015 to 2020 revealed that only 67 (0.85%) were related to perioperative airway management, indicating that while these incidents are relatively rare, they can still pose significant risks to patients.

The most common adverse event was 'Intubation Injury,' accounting for 35.8% of airway management incidents, with the majority of events causing temporary or minor harm, highlighting the need for improved training and resources to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. Osgood, KB., Krishnan, S., Wheeler, KK., et al.[2022]

Citations

1. inogen.com inogen.com/oxygen-therapy/clinical-efficacy/?srsltid=AfmBOoo76TGCG2pGSje_vSp-whpOREU2_oJRoPUVmkoSod9fnl3tLvs4

Inogen's Oxygen Concentrators Clinical Efficacy Inogen supports patient respiratory care by developing, manufacturing, and marketing innovative best-in-class portable oxygen concentrators used to deliver ...

2. withpower.com withpower.com/trial/phase-obstructive-apnea-2023-bd6a5

Portable Oxygen Concentrator for Obstructive Sleep Apnea Research shows that using a portable oxygen concentrator with an auto-demand function can improve oxygen levels during sleep and reduce the number of breathing ...

3. investor.inogen.com investor.inogen.com/news-events/press-releases/detail/230/inogen-announces-publication-of-study-demonstrating-the

Inogen Announces Publication of Study Demonstrating the ... The results showed that portable oxygen concentrator (POC) use, either alone or in combination with other oxygen modalities, was associated with ...

4. provider.inogen.com provider.inogen.com/clinical

Clinical Evidence Summary Read the full studies below that demonstrate the impact of portable oxygen concentrators and pulse dose oxygen delivery for patients' long-term oxygen therapy.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06609694/comparison-of-a-demand-oxygen-delivery

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

6. inogen.com inogen.com/wp-content/uploads/2024/07/Clinical-Evidence-Summary-Brochure.pdf?srsltid=AfmBOoq7sePJh-7HitRF-VtNfozEad1NwcHe9_KcEX8ZkKqcGOY02SN0

Portable Oxygen Concentrators - Clinical Evidence Summary Objective. The primary objective of this study was to evaluate the health impact of Long-Term Oxygen Therapy (LTOT) according to the different ...

7. inogen.com inogen.com/oxygen-therapy/clinical-efficacy/?srsltid=AfmBOorVAA_Cndr-zvv5W52gDoQ-IcN6UXMSM0mRmfpAzeSdOfwAIVjc

Inogen's Oxygen Concentrators Clinical Efficacy Inogen supports patient respiratory care by developing, manufacturing, and marketing innovative best-in-class portable oxygen concentrators used to deliver ...