Sleep Apnea Syndromes Clinical Trial
Official title:
Cycloserine in the Treatment of Sleep Apnea
This study is being conducted to determine whether cycloserine is effective for the treatment of sleep apnea. Cycloserine is an antibiotic that has been extensively used in the treatment tuberculosis. However, more recently it was shown to enhance memory responses. Cycloserine may enhance the response of respiratory muscles to apnea and potentially reduce the severity of sleep disordered breathing.
The passive human upper airway (UA) is a collapsible tube with a relatively high compliance.
At atmospheric luminal pressure, its cross-sectional area varies considerably. Subjects in
whom the pharynx is closed, or nearly closed, at near atmospheric pressure require an upper
airway dilating force to maintain adequate ventilation. During wakefulness pharyngeal dilator
muscles (dilators) provide the necessary force to permit an adequate flow, regardless of how
collapsible the pharynx is. This dilator activity is substantially lost at sleep onset.
Subjects in whom the passive UA cannot permit adequate ventilation must recruit dilators
through reflex mechanisms if they are to remain asleep. Recent studies have shown that
activation of the muscles that open the airway in the course of obstructive apneas persists
to a variable degree after the relief of obstruction, evidencing the presence of memory for
prior activation in the the brain centers that supply the dilator muscles.
Short-term potentiation (STP) is a neuro-physiological mechanism that results in a
time-dependent increase in motor activity, that is not explainable by changes in stimulus
intensity, and which persists after disappearance of the stimulus ( "after-discharge"). STP
is well documented in diaphragmatic responses to chemical stimuli. Prominent STP in upper
airway muscles would promote a stronger dilator response to upper airway occlusion. The
after-discharge would also help to maintain dilator activity following the ventilatory phase
of obstructive events, thereby mitigating recurrence of obstruction. Patients with
obstructive sleep apnea (OSA) vary greatly in the extent to which this memory or STP is
present. The investigators postulate that interventions that could potentiate the development
of memory for prior activation would mitigate the recurrence of apneas and reduce the
severity of obstructive sleep apnea. The same interventions, those that enhance memory for
prior activation, would also likely improve central apneas in that these apneas represent
loss of diaphragm activity following hyperventilation. Memory for prior activation of the
diaphragm has been well documented in the past and appears to be defective in such patients.
There has been extensive research into methods of improving neural memory. Cycloserine, an
antibiotic that has been, and continues to be, used extensively in the treatment of
drug-resistant tuberculosis, was shown to be effective in promoting memory in small doses
(much less than those used for tuberculosis) both in animals and humans. We, therefore,
propose that cycloserine has the potential of enhancing the memory properties of neurones
supplying pharyngeal muscles and propose to study the effect of using it on the severity of
sleep apneas of the obstructive and central varieties.
Patients who have been diagnosed with OSA following routine clinical sleep studies will be
asked to participate. Participation involves agreeing to two additional full night studies in
the sleep laboratory, separated by 1 week. Both studies will be identical to the routine
clinical studies, except that the patient will be asked to swallow a capsule containing
either placebo or 250 mg cycloserine 1 to 2 hours prior to going to sleep. The order of the
Placebo and Test nights will be randomized. The patient will be monitored continuously by a
dedicated, senior polysomnography technologist.
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