Sleep Apnea Syndrome and Vitamin D

NCT01323218 | Unknown Phase 2

• 1 other identifier: CHU-0091
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea-hypopnea Syndrome

Keywords

Obstructive sleep apnea-hypopnea syndrome; OSAHS; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Interventions

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 25, 2011

Record last verified: 2011-03

Locations

FR (1)