Baclofen and Hypoxia-induced Periodic Ventilation

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Periodic ventilation that includes CHEYNE Stokes ventilation is a pathological pattern characterized by alternating periods of hyperpneas and apnea-hypopneas. It occurs generally during sleep, at high altitude and in hypoxic conditions in healthy subjects, and in some diseases like congestive heart failure. One study conducted on an animal model suggested that baclofen, a drug already used against spasticity in humans, could also be effective against periodic ventilation. The goal of the study is therefore to assess this hypothesis on hypoxia-induced periodic ventilation in healthy subjects during sleep.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Baclofen; GABA-B Receptor Agonists

Criteria

Inclusion Criteria:

• Adult

• Male

• Body mass index between 20 and 30 kg/m2

• Healthy (no known disease)

• No regular treatment except first grade antalgic drugs (e. g. ACETAMINOFEN)

• Written consent to participate in the study

• Health insurance

Exclusion Criteria:

• Intolerance to baclofen

• Tobacco, alcohol or drug consumption

• Past history of possible acute mountain sickness

• Regular treatment for any disease

• Claustrophobia

• Coronary disease

• Hypertension

• Cardiac failure

• Cardiac rhythm abnormalities

• Pulmonary hypertension

• Any pulmonary artery abnormality

• Any cardiac disease

• Past history of cerebral ischemia

• Past history of psychiatric disorder

• Any respiratory disease (including asthma)

• Leg arteriopathy

• Sickle cell anemia

• Renal insufficiency

• Migraine

• Diabetes

• Obesity

• Thalassemia

• Scoliosis

• Past history of phlebitis