Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea
|ClinicalTrials.gov Identifier: NCT01041924|
Recruitment Status : Unknown
Verified January 2010 by Imperial College London.
Recruitment status was: Not yet recruiting
First Posted : January 5, 2010
Last Update Posted : January 5, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Central||Other: Carbon dioxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Dynamic Carbon Dioxide Administration for Central Sleep Apnoea in Heart Failure|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2010|
- Other: Carbon dioxide
2% inhaled CO2 for up to 8 hours.
- Other: Carbon dioxide
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 ]
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): NCT01041924
|Foundation G. Monasterio|
|Pisa, Italy, 56124|
|Imperial NHS Trust|
|London, United Kingdom, W21NY|
|Principal Investigator:||Darrel P Francis, MD||Imperial College London|