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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine d'Auvergne | OTHER_GOV |
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
| Laboratoire Crinex | UNKNOWN |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 OH vitamin D | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep | at the beginning (day 0) and after 32 days of vitamin D supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth sleepiness scale | 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) | at the beginning (day 0) and after 32 days of vitamin D supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Laboratoire Cidelec |
| UNKNOWN |
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| Continuous positive airway pressure measured with a CPAP equipment | at the beginning (day 0) and after 32 days of vitamin D supplementation |
| Muscular strength measured with handgrip test | 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 | at the beginning (day 0) and after 32 days of vitamin D supplementation |
| Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP) | at the beginning (day 0) and after 32 days of vitamin D supplementation |
| Analysis of genes implicated in vitamin D metabolism | at inclusion. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |