Sleep Apnea Syndrome and Vitamin D

University Hospital, Clermont-Ferrand

Status and phase

Unknown

Phase 2

Conditions

Obstructive Sleep Apnea-hypopnea Syndrome

Treatments

Drug: 25 OH vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT01323218

CHU-0091

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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