Cycloserine in the Treatment of Sleep Apnea

NCT02735694 | Terminated Phase 1 DMC

• 3 other identifiers: B2013:044MA-79549427-U0304-36C
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sleep Apnea Syndromes

Keywords

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

Outcome Measures

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

  Baseline and one week

Secondary Outcomes (2)

• Improvement in total sleep time

  Baseline and one week

• Improvement in average oxygen saturation

  One week

Other Outcomes (1)

• Improvement in the awakening and arousals index

  One week

Study Arms (2)

Cycloserine

ACTIVE COMPARATOR

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

Drug: Cycloserine; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Cycloserine; Drug: Placebo

Interventions

Cycloserine DRUG

Capsule containing 250 mg of Cycloserine

Also known as: Seromycin

Cycloserine; Placebo

Placebo DRUG

Sugar capsule manufactured to mimic Cycloserine 250 mg capsule

Also known as: Sugar capsule

Cycloserine; Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• University of Calgary: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Sleep Disorders Centre

Winnipeg, Manitoba, R3C 1A2, Canada

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Cycloserine; Sugars

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Officials

• Magdy K Younes, Md, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: April 13, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 17, 2019

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)