Obstructive Sleep Apnea Clinical Trial
Official title:
Effect of Increasing Respiratory Drive on Severity of Obstructive Apnea
This study is being conducted to determine whether inhaling exhaled carbon dioxide is effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.
During wakefulness pharyngeal dilator muscles (dilators) provide the necessary force to
permit an adequate flow in all subjects regardless of how collapsible their passive pharynx
is. This dilator activity is substantially lost at sleep onset. Subjects in whom the passive
pharynx cannot permit adequate ventilation must recruit dilators through reflex mechanisms
if they are to remain asleep. Dilators can be recruited reflexly via changes in blood gas
tensions and in afferent activity of pharyngeal mechanoreceptors.
Patients with obstructive sleep apnea (OSA) develop repetitive obstructive events during
which air flow decreases substantially (hypopneas) or ceases altogether (apneas). These last
from 10 to >60 seconds following which there is a substantial increase in ventilation
(hyperventilatory phase) that lasts for several breaths. The cycle then repeats. Arousal
from sleep occurs at some point during the hyperventilatory phase in the vast majority of
obstructive respiratory events. However it has been shown that in the majority of OSA
patients, the reflex mechanisms are competent and can deal with the obstruction without
arousal. The respiratory drive must increase a finite amount before the upper airway muscles
begin responding to increasing respiratory drive, and often the patient wakes up first.
Thus, when a subject with a narrowed or more compliant pharynx falls asleep and obstructs
his/her airway, blood gas tensions must deteriorate a threshold amount before the pharyngeal
dilators begin responding. Once this threshold is reached, the dilators respond briskly to
further changes in blood gas tensions and open the airway. This threshold was termed the
Effective Recruitment Threshold (TER).
The basis for this research project is that if respiratory drive can be maintained at or
near the threshold, the dilators would respond promptly to any obstruction and there would
be little further increase in respiratory drive during obstruction.We estimate that the
required increase in drive can be attained by simply raising carbon dioxide pressure (PCO2)
2-3 mmHg, a highly tolerable increase. We intend to increase respiratory drive on a
continuous basis, beginning before sleep by asking the participants to breath through a
regular continuous positive airway pressure (CPAP) mask with added dead space.
To increase dead-space we will modify commercial rebreathing bags used for oxygen therapy so
that the amount of rebreathing can be adjustable. This should raise arterial carbon dioxide
pressure (PaCO2) a few millimetres of mercury (mmHg) in the steady state. Upon sleep, the
respiratory drive would be at or above TER in nearly half the patients. Should the airway
obstruct, the dilator muscles would be in a position to respond promptly, preventing an
acute further rise in respiratory drive. This will reduce the frequency of obstructive
respiratory events by >50% in at least half the patients, and improve sleep quality and
nocturnal oxygen saturation.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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