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TerminatedNCT02735694Updated Sep 17, 2019

Cycloserine in the Treatment of Sleep Apnea

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

Why this study was terminated
Analysis of initial sample shows negative results.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Sleep Apnea Syndromes

Keywords

  • Sleep apnea
  • Hypoglossal Nerve
  • N-methyl-D-aspartate receptors
  • Cycloserine
  • Short-term potentiation
03

In context

Apnea

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Moderate to severe obstructive or central sleep apnea (Apnea Hypopnea Index > 30/hr).
  • Minimum Oxygen saturation during respiratory events >70% throughout sleep during the clinical sleep study.

Exclusion criteria

Exclusion Criteria:

  • Contraindication to the use of cycloserine, namely history of allergy to cycloserine, seizures, depression, severe anxiety or psychosis, excessive use of alcohol or renal failure.
  • Past or current history of tuberculosis
  • Hypercapnia > 55 millimeters of mercury during the diagnostic clinical sleep study.
  • Neuromuscular disease.
  • Obesity-hypoventilation syndrome.
  • Pregnancy.
  • Significant co-morbidities: Dialysis-dependant renal failure, severe asthma or chronic lung disease, congestive heart failure, previous stroke.
  • Recent (within 3 months) myocardial infarction or Active coronary ischemia event.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Cycloserine

    Cycloserine, 250 mg capsules by mouth, one hour prior to initiation of sleep study, single dose

    Drug: Cycloserine · Drug: Placebo

  • Placebo comparator
    Placebo

    Placebo, sugar capsule by mouth, one hour prior to initiation of sleep study, single dose

    Drug: Cycloserine · Drug: Placebo

Interventions

  • DrugCycloserine

    Capsule containing 250 mg of Cycloserine

    Also known as: Seromycin

  • DrugPlacebo

    Sugar capsule manufactured to mimic Cycloserine 250 mg capsule

    Also known as: Sugar capsule

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Improvement in total sleep time

    Time frame: Baseline and one week

  2. Improvement in average oxygen saturation

    Time frame: One week

Other outcomes

  1. 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

07

Study locations

2 sites
  • University of Calgary
    Calgary, Alberta T2N 4N1, Canada
  • Sleep Disorders Centre
    Winnipeg, Manitoba R3C 1A2, Canada
08

References and documents

Individual participant data

Plan to share: No — No plan has been made on sharing individual data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02735694
Lead sponsor
University of Manitoba
Collaborators
University of Calgary
Responsible party
Sponsor
First posted
Apr 13, 2016
Start date
Sep 2015
Primary completion
Jun 2016
Completion
Nov 2016
Last update
Sep 17, 2019

Study contacts

Magdy K Younes, Md, PhD
principal investigator · University of Manitoba

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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