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Clinical Trial Summary

The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.

The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.


Clinical Trial Description

OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.

DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.

METHODS: To all subjects included in the study, the following procedures will be performed:

1. Medical History;

2. Anthropometric variables (height, weight, Body Mass Index;

3. Somnolence evaluation using the Epworth scale;

4. Conventional Polysomnography (PSG);

5. Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.

6. Conventional biologic evaluation;

7. Patients will be re-evaluated after three months of treatment with CPAP. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00456651
Study type Interventional
Source Sociedad Española de Neumología y Cirugía Torácica
Contact Mónica de la Peña, MD
Phone 34 971 175112
Email mdelapena@hsd.es
Status Recruiting
Phase N/A
Start date February 2007

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