Back to resultsVariable Dead Space Rebreathing Device to Treat Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive, Sleep Apnea, Central
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart CO2
Sponsored by
About this trial
This is an interventional device feasibility trial for Sleep Apnea, Obstructive focused on measuring variable deadspace, rebreathe, hypercapnic side-effects
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years old, inclusive
- Moderate to severe OSA (Apnea hypopnea index [AHI] >15 events/hr of sleep)
- Newly diagnosed OSA, or have either refused to or have not tolerated PAP treatment, or are currently using Positive Airway Pressure (PAP) and are willing to hold it during the night of sleep study visits.
- Willing and able to provide consent to 5 laboratory visits with 4 full nights of sleep study.
- Self report of still having sleep apnea since the last sleep test (if diagnosis was greater than a year prior).
Exclusion Criteria:
- BMI >45 kg/m2
- AHI<15 events/hour on the first night of sleep testing in our research laboratory (Visit 2)
- Cigarette smoking of 1 pack per day or more within 6 months of screening;
- Diagnosed heart failure or coronary artery disease.
- Diagnosed cerebrovascular disease, Transient Ischemic Attack (TIA) or stroke.
- Diagnosed asthma or chronic obstructive pulmonary disease with significant airways obstruction (FEVI/Forced Vital Capacity <65%)
- End-stage hepatic or renal disease
- Significant daytime sleepiness in subjects who have risky occupations or life-style (for example, working in the transportation industry, history of motor vehicle crash, occupation that requires vigilance for safety or performance)
- Pregnancy (assessed on urine test at V1 in females with childbearing potential)
- Clinically significant arrhythmia/dysrhythmias on the clinical diagnostic polysomnography (per medical record) or on research polysomnography conducted at V2
- Established diagnosis of neuromuscular disease (e.g., Parkinsonism, multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis, poliomyelitis, Eaton-Lambert, Guillain-Barre, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
- Any current use of benzodiazepines, opioids, or barbiturates
- Any medical or psychiatric condition which in the opinion of the medical director interferes with the subject's ability to enroll or to continue in the study (once enrolled)
- Veteran, cared for in the VA system
Sites / Locations
- University of Wisconsin Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Smart CO2
No intervention
Arm Description
Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure.
Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Aim 2: Effect on Sleep state stability
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)
To determine whether this novel treatment influences systolic or diastolic blood pressure following sleep.
Full Information
NCT ID
NCT03552133
First Posted
May 7, 2018
Last Updated
December 13, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03552133
Brief Title
Variable Dead Space Rebreathing Device to Treat Sleep Apnea
Official Title
Feasibility of a Variable Carbon Dioxide (CO2) Rebreathe Device ("Smart CO2") to Treat Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Sleep Apnea, Central
Keywords
variable deadspace, rebreathe, hypercapnic side-effects
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One control study night vs. two intervention study nights (subject serves as own control).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smart CO2
Arm Type
Experimental
Arm Description
Effects of rebreathe device over two sleep nights on sleep apnea, hypoxemia, sleep state, and blood pressure.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Effects of control night, i.e. no intervention on sleep apnea, hypoxemia, sleep state, and blood pressure.
Intervention Type
Device
Intervention Name(s)
Smart CO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aim 1: Determine the effects of Smart CO2 Device on AHI
Description
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
Title
Determine the effect of Smart C02 Device on Arousal Index
Description
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
Secondary Outcome Measure Information:
Title
Aim 2: Effect on Sleep state stability
Description
To determine whether this novel treatment influences sleep state stability following sleep.
Time Frame
Three to six weeks
Title
Determine the effects of Smart CO2 device on Blood pressure (both systolic and diastolic measures)
Description
To determine whether this novel treatment influences systolic or diastolic blood pressure following sleep.
Time Frame
Three to six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-75 years old, inclusive
Moderate to severe OSA (Apnea hypopnea index [AHI] >15 events/hr of sleep)
Newly diagnosed OSA, or have either refused to or have not tolerated PAP treatment, or are currently using Positive Airway Pressure (PAP) and are willing to hold it during the night of sleep study visits.
Willing and able to provide consent to 5 laboratory visits with 4 full nights of sleep study.
Self report of still having sleep apnea since the last sleep test (if diagnosis was greater than a year prior).
Exclusion Criteria:
BMI >45 kg/m2
AHI<15 events/hour on the first night of sleep testing in our research laboratory (Visit 2)
Cigarette smoking of 1 pack per day or more within 6 months of screening;
Diagnosed heart failure or coronary artery disease.
Diagnosed cerebrovascular disease, Transient Ischemic Attack (TIA) or stroke.
Diagnosed asthma or chronic obstructive pulmonary disease with significant airways obstruction (FEVI/Forced Vital Capacity <65%)
End-stage hepatic or renal disease
Significant daytime sleepiness in subjects who have risky occupations or life-style (for example, working in the transportation industry, history of motor vehicle crash, occupation that requires vigilance for safety or performance)
Pregnancy (assessed on urine test at V1 in females with childbearing potential)
Clinically significant arrhythmia/dysrhythmias on the clinical diagnostic polysomnography (per medical record) or on research polysomnography conducted at V2
Established diagnosis of neuromuscular disease (e.g., Parkinsonism, multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis, poliomyelitis, Eaton-Lambert, Guillain-Barre, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
Any current use of benzodiazepines, opioids, or barbiturates
Any medical or psychiatric condition which in the opinion of the medical director interferes with the subject's ability to enroll or to continue in the study (once enrolled)
Veteran, cared for in the VA system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome A Dempsey, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53726
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Variable Dead Space Rebreathing Device to Treat Sleep Apnea
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