An interventional study of Breath-synchronized oxygen and CPAP in Oxygen Desaturation, Apnea (Central and Obstructive) and Airway Obstruction, sponsored by University of Utah. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%) events in colonoscopy patients receiving one of three different methods of supplemental oxygen administration. The first method is standard-of-care continuous flow oxygen therapy, where a constant flow of oxygen is administered through a nasal cannula or oxygen mask. The second method is synchronized flow oxygen therapy. This is a delivery method implemented in an FDA-cleared medical device (Sovant, Dynasthetics LLC) which delivers variable-volume oxygen pulses only as the patient inhales. The delivered oxygen pulses are commensurate to the set flow rate and the patient's respiratory rate. The third method is continuous positive airway pressure therapy (CPAP), where non-invasive pressure support is given to the patient's airway to help keep their airway open. The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation events compared to traditional continuous flow oxygen therapy.
Sedation procedures such as colonoscopies involve administering drugs to patients that reduce awareness and pain without complete loss of consciousness. A side effect of these drugs is respiratory depression, where the patient's breathing becomes more shallow and less frequent. Another side effect is partial or complete obstruction of the airway by the airway tissue, inhibiting the flow of oxygen to the lungs. When a patient experiences significant respiratory depression or airway obstruction, they may not receive adequate oxygen, which may result in low hemoglobin oxygen saturation (SpO2), which is generally monitored with a probe on a finger. This may lead to inadequate oxygenation of tissues or organs and can lead to permanent organ damage or even death in severe cases.
The current standard approach to prevent oxygen desaturation during procedural sedation is supplemental oxygen therapy, usually administered through a nasal cannula or oxygen mask. The traditional method is continuous flow oxygen therapy, where a constant flow of oxygen is given. Research has demonstrated that while this does improve overall oxygen saturation levels during sedation, oxygen desaturation and apnea still frequently occur.
An FDA-cleared intelligent oxygen delivery device (Sovant, Dynasthetics LLC) that is relatively new to the market provides a new approach to supplemental oxygen delivery called synchronized flow, which delivers variable-volume pulses of high-flow oxygen only as the patient inhales. The volumes of the pulses are based on a set flow rate and the patients respiratory rate. Research has shown that higher oxygen concentrations reach the lungs when using synchronized flow delivery as opposed to continuous flow oxygen delivery, but research has yet to demonstrate that synchronized flow reduces oxygen desaturation events.
Research has demonstrated that continuous positive airway pressure (CPAP) therapy, which involves directing air flow into a tight-fitting mask over the patient's nostrils and/or mouth to stent open the airway, effectively reduces oxygen desaturation and apnea when administered with a non-invasive ventilator. However, non-invasive ventilators used for administering PAP therapy are expensive, large, require special training to operate, and often are not available in areas of the hospital where sedation procedures take place, making this a less-practical approach.
We have developed a smaller low-cost CPAP system for sedation as an additional software feature and disposable integrated into the FDA-cleared intelligent oxygen delivery device that also administers continuous flow and synchronized flow supplemental oxygen (Sovant, Dynasthetics LLC). The aim of the study is to administer supplemental oxygen to colonoscopy patients using these three different administration methods (continuous flow, synchronized flow, and CPAP therapy) and evaluate differences in oxygen desaturation (SpO2 \< 90%) and apnea (10 seconds or more without respiration) events. We aim to evaluate the effectiveness of synchronized flow oxygen delivery compared to continuous flow oxygen delivery in reducing oxygen desaturation and apnea. We also aim to evaluate whether our compact and low-cost CPAP system can also effectively reduce oxygen desaturation and apnea compared to the current standard practice of continuous flow delivery.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 280 is above the median of 60 across 195 interventional studies indexed under Apnea.
Browse Apnea studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist.
Device: Control
This arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath.
Device: Breath-synchronized oxygen
This arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist.
Device: CPAP
This is breath-synchronized oxygen delivery of supplemental oxygen by the FDA-cleared Sovant device, where oxygen is given synchronously with the patient's inhalation only through a nasal cannula or non-rebreather oxygen mask.
Also known as: Synchronized Flow
Supplemental oxygen delivered via continuous positive airway pressure (CPAP) therapy through a tight-fitting mask over the patient's mouth and nose, where oxygen flow rate is automatically adjusted by the investigational devce to maintain the anesthetist-selected airway pressure.
This is the traditional approach of administering oxygen at a constant flow rate chosen by the anesthetist through a nasal cannula or non-rebreather oxygen mask.
Also known as: Continuous flow
Oxygen Saturation AUC
The area under the hemoglobin oxygen saturation curve (AUC) will be calculated as the difference between the desaturation threshold of 90% and the recorded SpO2 integrated over the duration that SpO2 was below the 90% threshold.
Time frame: The duration of the procedure
Apneic events
The number and duration of apneic events, with apnea defined as 10 seconds or more without respiration.
Time frame: The duration of the procedure
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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