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| ID | Type | Description | Link |
|---|---|---|---|
| A538500 | Other Identifier | UW Madison | |
| SMPH/POP HEALTH SCI/POP HEALTH | Other Identifier | UW Madison | |
| 1R21HL137874-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart CO2 | Experimental | Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure. |
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| No intervention | No Intervention | Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart CO2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | three to six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 2: Effect on Sleep state stability | To determine whether this novel treatment influences sleep state stability following sleep. | Three to six weeks |
| Determine the effects of Smart CO2 device on Blood pressure (both systolic and diastolic measures) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome A Dempsey, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Madison | Madison | Wisconsin | 53726 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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One control study night vs. two intervention study nights (subject serves as own control).
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To determine whether this novel treatment influences systolic or diastolic blood pressure following sleep. |
| Three to six weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |