Variable Dead Space Rebreathing Device to Treat Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03552133|
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Sleep Apnea, Central||Device: Smart CO2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One control study night vs. two intervention study nights (subject serves as own control).|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility of a Variable Carbon Dioxide (CO2) Rebreathe Device ("Smart CO2") to Treat Obstructive Sleep Apnea|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||October 1, 2019|
Experimental: Smart CO2
Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure.
Device: Smart CO2
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.
No Intervention: No intervention
Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure.
- Aim 1: Determine the effects of Smart CO2 Device on AHI [ Time Frame: three to six weeks ]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.
- Determine the effect of Smart C02 Device on Arousal Index [ Time Frame: three to six weeks ]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.
- Aim 2: Effect on Sleep state stability [ Time Frame: Three to six weeks ]To determine whether this novel treatment influences sleep state stability following sleep.
- Determine the effects of Smart CO2 device on Blood pressure (both systolic and diastolic measures) [ Time Frame: Three to six weeks ]To determine whether this novel treatment influences systolic or diastolic blood pressure following sleep.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552133
|United States, Wisconsin|
|University of Wisconsin Madison|
|Madison, Wisconsin, United States, 53726|
|Principal Investigator:||Jerome A Dempsey, PhD||University of Wisconsin, Madison|