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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 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 interruptions in people with obstructive sleep apnea. This suggests it may help improve sleep quality and reduce symptoms. ^{1 2 3 4 5}

Is portable oxygen concentrator therapy generally safe for humans?

The research articles provided do not contain specific safety data on portable oxygen concentrators or related oxygen therapies for obstructive sleep apnea or other conditions. ^{6 7 8 9 10}

How is the portable oxygen concentrator with demand oxygen delivery different from other treatments for obstructive sleep apnea?

The portable oxygen concentrator with demand oxygen delivery is unique because it automatically adjusts oxygen flow based on the user's breathing patterns, providing pulsed oxygen when it detects apnea (pauses in breathing), unlike traditional continuous-flow systems. ^{1 2 11 12 13}

Research Team

Raouf Amin, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized cross-over trial of demand oxygen delivery system. [2022]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Nocturnal oxygen enrichment in sleep apnoea. [2017]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A Decade of Difficult Airway Response Team: Lessons Learned from a Hospital-Wide Difficult Airway Response Team Program. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Incidents during out-of-hospital patient transportation. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Patient safety events in out-of-hospital paediatric airway management: a medical record review by the CSI-EMS. [2018]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Performance comparison of 4 portable oxygen concentrators. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

The cost of breathing: an economic analysis of the patient cost of home oxygen therapy. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Portable pulse-dose oxygen concentrators should not be used with noninvasive ventilation. [2013]