Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities. OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus. A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.
Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D. After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies
CHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGApnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Epworth sleepiness scale
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2)
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Continuous positive airway pressure measured with a CPAP equipment
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Muscular strength measured with handgrip test
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Analysis of genes implicated in vitamin D metabolism
Time frame: at inclusion.
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