An interventional study of Smart CO2 in Sleep Apnea, Obstructive and Sleep Apnea, Central, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Device feasibility
The purpose of this pilot study is to determine the feasibility of using a novel treatment for sleep apnea in which the patient's own exhaled CO2 is tightly controlled and used in a rebreathe system to reduce sleep disordered breathing.
Obstructive sleep apnea (OSA) needs to be treated with devices that will be utilized with greater compliance by patients than is currently the case with positive airway pressure. To this end, the investigators recently showed that increased inspired CO2 via rebreathing was effective in reducing most obstructive and central apneas in OSA patients. Then, the investigator's University of Wisconsin (UW) team of bioengineers, physiologists, and sleep physicians built a novel variable dead space rebreathe device-with no added positive pressure-which monitors breath by breath ventilation and automatically adjusts the rebreathe dead space volume to add or subtract the level of inspired CO2 depending on the degree of sleep disordered breathing. This approach provides the minimum effective CO2 dose needed in individual OSA patients to stabilize central respiratory motor output and to recruit upper airway dilator muscles, thereby treating obstructive and central apneas. The investigators propose to determine the effectiveness of this "Smart CO2" treatment as well as its effects on sleep state stability, sleep quality, and blood pressure in 10 moderate to severe OSA patients studied over several nights. The investigators expect the findings from the proposed study to be sufficient to determine if the "Smart CO2" treatment is a viable approach to OSA treatment worthy of testing in a clinical trial.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 13 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
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Exclusion Criteria:
Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure.
Device: Smart CO2
Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure.
A lightweight, cylindrical reservoir attached to a face mask which monitors breathing breath-by-breath and automatically adjusts the level of dead space rebreathe volume so that CO2 will be increased and sleep apnea treated.
Aim 1: Determine the effects of Smart CO2 Device on AHI
To determine the effects of a novel, adjustable CO2 rebreathing device on the occurrence of sleep apnea (AHI) in patients with moderate to severe obstructive sleep apnea.
Time frame: three to six weeks
Determine the effect of Smart C02 Device on Arousal Index
To determine the effects of a novel, adjustable CO2 rebreathing device on the occurrence of sleep apnea (Arousal Index) in patients with moderate to severe obstructive sleep apnea.
Time frame: three to six weeks
Aim 2: Effect on Sleep state stability
To determine whether this novel treatment influences sleep state stability following sleep.
Time frame: Three to six weeks
Determine the effects of Smart CO2 device on Blood pressure (both systolic and diastolic measures)
To determine whether this novel treatment influences systolic or diastolic blood pressure following sleep.
Time frame: Three to six weeks
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2016, a primary completion of Oct 2019 and a completion of Oct 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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