A Phase 2 interventional study of Carbon dioxide and Carbon dioxide in Sleep Apnea, Central, sponsored by Imperial College London. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-01-05.
Sponsored by Imperial College London · Phase 2, Interventional, and Treatment
Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA).
Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities.
As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing.
There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels.
We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2% inhaled CO2 for up to 8 hours.
Up to a maximum of 2% CO2, only delivered for a maximum of up to 20 seconds per 60 seconds for 8 hours
Extent of respiratory instability
Time frame: over 8 hours
Arousals
Time frame: over 8 hours
End-tidal CO2
Time frame: per breath
24 hour urinary catecholamines
Time frame: per 24 hours
Mean heart rate
Time frame: per 1 s
Number of ectopic heart beats
Time frame: per 8 hours
Mean blood pressure
Time frame: every 9 hours
Mean Ventilation
Time frame: every 1 second
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Imperial College London