Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea

Sleep Apnea, Central Clinical Trial

Official title:

Dynamic Carbon Dioxide Administration for Central Sleep Apnoea in Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01041924
• Other study ID #: FS/04/079
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 4, 2010
• Last updated: January 4, 2010
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2010
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month;

• An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive.

Exclusion Criteria:

• Pregnancy,

• Myocardial infarction,

• Unstable angina or cardiac surgery within the previous three months.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

Other:
• Carbon dioxide
2% inhaled CO2 for up to 8 hours.
• 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

Locations

Country	Name	City	State
Italy	Foundation G. Monasterio	Pisa
United Kingdom	Imperial NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of respiratory instability		over 8 hours	No
Primary	Arousals		over 8 hours	No
Secondary	End-tidal CO2		per breath	No
Secondary	24 hour urinary catecholamines		per 24 hours	No
Secondary	Mean heart rate		per 1 s	No
Secondary	Number of ectopic heart beats		per 8 hours	No
Secondary	Mean blood pressure		every 9 hours	No
Secondary	Mean Ventilation		every 1 second	No

External Links

•   mathematical modelling work