Sleep Apnea Syndrome and Vitamin D

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
• Intervention / Treatment: Drug: 25 OH vitamin D

Detailed Description

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
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate to severe obstructive sleep apnoea (AHI > 15)
• With or without continuous positive airway pressure for a minimum of six months
• aged 30-75 years
• Vitamin D2D3 level < 30 ng/ml

Exclusion Criteria:

• Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism
• Patients with mixed sleep apnoea (central and obstructive)
• Patients with CPAP use < 4 hours per night
• Patients with maxillofacial or oro-pharyngeal diseases)
• Patients with chronic respiratory failure, hypercapnic patients
• Muscle diseases
• Alcohol intake > 2 glasses per day
• Body mass index > 40 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe; Centre de Recherche en Nutrition Humaine d'Auvergne; Laboratoire Crinex; Laboratoire Cidelec

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2011
• Last Update Submitted That Met QC Criteria: March 24, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin D; OSAHS; Obstructive sleep apnea-hypopnea syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: CHU-0091