Variable Dead Space Rebreathing Device to Treat Sleep Apnea

Completed · Not applicable

Conditions studied: Sleep Apnea, Obstructive, Sleep Apnea, Central

In brief

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.

Key facts

Study ID

NCT03552133

Run by

University of Wisconsin, Madison

People needed

13

Starts

2016-08-01

Expected to finish

2019-10-01

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of Wisconsin Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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