A Phase 1 interventional study of Cycloserine and Placebo in Sleep Apnea Syndromes, sponsored by University of Manitoba. Terminated at 2 sites in Canada. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by University of Manitoba · Phase 1, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cycloserine, 250 mg capsules by mouth, one hour prior to initiation of sleep study, single dose
Drug: Cycloserine · Drug: Placebo
Placebo, sugar capsule by mouth, one hour prior to initiation of sleep study, single dose
Drug: Cycloserine · Drug: Placebo
Capsule containing 250 mg of Cycloserine
Also known as: Seromycin
Sugar capsule manufactured to mimic Cycloserine 250 mg capsule
Also known as: Sugar capsule
Change in Apnea-hypopnea index (AHI)
Baseline apnea-hypopnea index in first night and upon end of the second sleep study, performed one week apart
Time frame: Baseline and one week
Improvement in total sleep time
Time frame: Baseline and one week
Improvement in average oxygen saturation
Time frame: One week
Improvement in the awakening and arousals index
number of awakenings and arousals per hour of sleep as measurement of sleep continuity.
Time frame: One week
Plan to share: No — No plan has been made on sharing individual data
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of Manitoba