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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
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Sleep Apnea, Central Device: Smart CO2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-75 years old, inclusive
  2. Moderate to severe OSA (Apnea hypopnea index [AHI] >15 events/hr of sleep)
  3. 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.
  4. Willing and able to provide consent to 5 laboratory visits with 4 full nights of sleep study.
  5. Self report of still having sleep apnea since the last sleep test (if diagnosis was greater than a year prior).

Exclusion Criteria:

  1. BMI >45 kg/m2
  2. AHI<15 events/hour on the first night of sleep testing in our research laboratory (Visit 2)
  3. Cigarette smoking of 1 pack per day or more within 6 months of screening;
  4. Diagnosed heart failure or coronary artery disease.
  5. Diagnosed cerebrovascular disease, Transient Ischemic Attack (TIA) or stroke.
  6. Diagnosed asthma or chronic obstructive pulmonary disease with significant airways obstruction (FEVI/Forced Vital Capacity <65%)
  7. End-stage hepatic or renal disease
  8. 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)
  9. Pregnancy (assessed on urine test at V1 in females with childbearing potential)
  10. Clinically significant arrhythmia/dysrhythmias on the clinical diagnostic polysomnography (per medical record) or on research polysomnography conducted at V2
  11. 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)
  12. Any current use of benzodiazepines, opioids, or barbiturates
  13. 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)
  14. Veteran, cared for in the VA system

Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53726
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Jerome A Dempsey, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03552133     History of Changes
Other Study ID Numbers: 2016-0475
A538500 ( Other Identifier: UW Madison )
SMPH/POP HEALTH SCI/POP HEALTH ( Other Identifier: UW Madison )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of Wisconsin, Madison:
variable deadspace
rebreathe
hypercapnic side-effects
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases