Obstructive Sleep Apnea-hypopnea SyndromePhase 2NCT01323218
Sleep Apnea Syndrome and Vitamin D
A Phase 2 study testing 25 OH vitamin D in people with Obstructive Sleep Apnea-hypopnea Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea Syndrome
- What is being tested?
- 25 OH vitamin D
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
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.
Read the 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.
- Being tested
- 25 OH vitamin D
- Keywords
- Obstructive sleep apnea-hypopnea syndrome, OSAHS, Vitamin D
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 OH vitamin DDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep
Measured: at the beginning (day 0) and after 32 days of vitamin D supplementation
Secondary outcomes (7)
Epworth sleepiness scale
Measured: 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)
Measured: at the beginning (day 0) and after 32 days of vitamin D supplementation
Continuous positive airway pressure measured with a CPAP equipment
Measured: at the beginning (day 0) and after 32 days of vitamin D supplementation
Muscular strength measured with handgrip test
Measured: 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
Measured: at the beginning (day 0) and after 32 days of vitamin D supplementation
Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)
Measured: at the beginning (day 0) and after 32 days of vitamin D supplementation
Analysis of genes implicated in vitamin D metabolism
Measured: at inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-hypopnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire Crinex, Laboratoire Cidelec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323218
- Sponsor's protocol ID
- CHU-0091
- Status last verified
- Mar 2011
- First submitted
- 24 Mar 2011
- Last updated
- 25 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)
- ClinicalTrials.gov ID
- NCT01323218
- Acronym / sponsor ID
- CHU-0091
- Keywords
- Obstructive sleep apnea-hypopnea syndrome, OSAHS, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire Crinex, Laboratoire Cidelec
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 OH vitamin DAfter 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 | Drug | – |
Primary outcome
Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
7 secondary outcomes
Epworth sleepiness scale
Time frame: 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)
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Continuous positive airway pressure measured with a CPAP equipment
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Muscular strength measured with handgrip test
Time frame: 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
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)
Time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Analysis of genes implicated in vitamin D metabolism
Time frame: at inclusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 25 OH vitamin D in people with Obstructive Sleep Apnea-hypopnea Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep (time frame: at the beginning (day 0) and after 32 days of vitamin D supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2011.