Obstructive Sleep Apnea Syndrome
Conditions
Keywords
OSAS, Sleep Apnoea, IL6, TNFα, Oxidative Stress, Antioxidants
Brief summary
Obstructive Sleep Apnea Syndrome (OSAS) is associated with elevated plasma levels of IL-6 and TNF-α, which cannot be accounted for by obesity (Vgontzas et al Sleep Med Rev 2005;9:211-24, Ciftci et al Cytokine 2004;28:87-91\]. Obstructive apneas-hypopneas are accompanied by strenuous diaphragmatic contractions before the ensuing arousals and re-establishment of airway patency. We have shown that strenuous diaphragmatic contractions induced by resistive loading lead to elevated plasma levels of IL-6, TNF-α, and IL-1β (Vassi-lakopoulos et al AJRCCM 2002;166:1572-8) with concomitant up-regulation of the cytokines within the diaphragmatic myofibers (Vassilakopoulos et al AJRCCM 2004;170:154-61). OSAS patients exhibit frequent episodes of hypoxemia during the night. Loaded breathing is a form exercise for the respiratory muscles, and both acute and chronic hypoxia lead to an augmented plasma IL-6 response to exercise compared to normoxia (Lundby et al Eur J Appl Physiol 2004;91:88-93). In OSAS, monocytes have oxidative stress (Dyugovskaya et al AJRCCM 2002;165:934-9) and produce more cytokines (TNF-α) in vitro (Minoguchi et al Chest 204;126:1473-9). Hypothesis #1: plasma levels of IL-6 and TNF-α are increased during the night in OSAS patients secondary to the intermittent strenuous diaphragmatic contractions and the episodes of hypoxia-reoxygenation associated with the obstructive apneas-hypopneas. Hypothesis #2: monocytes from sleep apnea patients, exhibit augmented intracellular expression of IL-6 and TNF-α during the night. Hypothesis #3: Oxidative stress is a stimulus for cytokine upregulation in OSAS.
Interventions
DEVICEn-CPAP
administration of continuous positive airway pressure through a nasal device
DEVICEOxygen supplementation
Oxygen supplementation (3L) through nasal spectacles
DRUGVitamin A, Vitamin C, Vitamin E, Allopurinol, N-Acetylcysteine
Vitamin A 50,000 IU, Vitamin C 1000 mg , Vitamin E 200 mg, Allopurinol 600 mg, N-Acetylcysteine 2 g. Duration is set for 60 days
Sponsors
University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Obstructive Sleep Apnea Syndrome diagnosis
Exclusion criteria
* narcolepsy or idiopathic hypersomnia * chronic obstructive disease, * neuromuscular or endocrinological disease, * autoimmune systemic disease, * psychological disorders, * use of non steroids antinflammatory drugs, * use of cortisone drugs, * recent or concomitant systemic infections * upper or lower airway infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 Area under the curve | three months | The primary outcome measure ( IL-6 Area under the curve) is evaluated at the end of each polysonographic study. We anticipate each subject to have completed all three sudies within one month and receive the antioxidant supplementation for an additional 60 day period. In total three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TNF-a area under the curve | three months | The secondary outcome measure ( TNF-a Area under the curve) is evaluated at the end of each polysonographic study. we anticipate each subject to have completed all three sudies within one month and receive the antioxidant supplementation for an additional 60 day period. In total three months |
Countries
Greece
Contacts
Primary ContactGeorgios K Prezerakos, MD
Outcome results
None listed