Obstructive Sleep Apnea-hypopnea Syndrome Clinical Trial
Official title:
Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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