Baclofen and Hypoxia-induced Periodic Ventilation

• Register: ClinicalTrials.gov
• Last refreshed on: 5 November 2012
• Main ID: NCT01095679
• Date of registration: 29/03/2010
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Baclofen and Hypoxia-induced Periodic Ventilation PERIODIBAC
• Scientific title: Assessment of the Effect of the GABA-B Receptor Agonist, Baclofen, on Hypoxia-induced Periodic Ventilation, in Healthy Subjects
• Date of first enrolment: March 2010
• Target sample size: 53
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01095679
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Christian Straus, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

CHEYNE Stokes Respiration

Intervention(s)

Drug: Baclofen

Drug: Placebo

Primary Outcome(s)

Decrease in the coefficient of variation of the period of the ventilatory cycle [Time Frame: During the second and the third session in hypoxia]

Secondary Outcome(s)

Change in the non-linea dynamics of the ventilatory flow [Time Frame: During the second and the third session in hypoxia]

Decrease in the apnea-hypopnea index [Time Frame: During the second and the third session in hypoxia]

Decrease in the coefficient of variation of the end tidal CO2 pressure [Time Frame: During the second and the third session in hypoxia]

Decrease in the coefficient of variation of the tidal volume [Time Frame: During the second and the third session in hypoxia]

Decrease in the number of frequency compounds of the ventilatory flow [Time Frame: During the second and the third session in hypoxia]

Decrease in the sleep fragmentation index [Time Frame: During the second and the third session in hypoxia]

Secondary ID(s)

P090207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors