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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00213434 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
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Scientific title:
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Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome |
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Date of first enrolment:
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November 2001 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00213434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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PORTIER PF Florence, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de ROUEN |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30)
- Body mass index (BMI) < 35 Kg/m2
- Able to give their informed consent
Exclusion Criteria:
- Pregnant women
- Professional drivers requiring continuous positive airway pressure (CPAP) treatment
- Psychiatric disorders, and patients unable to realise to study
- Severe respiratory pathology which could interfere with the study
- Morpheic epilepsy
- Benzodiazepines intake
- Chronic nasal obstruction
- Ear, nose, and throat (ENT) pathology requiring surgery
- Previous uvulopalatoplasty surgery
- Temporomandibular joint pathology
- Gum disease
- Insufficient number of teeth to apply the oral appliance
- Mobile teeth
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea
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Intervention(s)
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Device: Herbst oral appliance
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Primary Outcome(s)
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Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
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Secondary Outcome(s)
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Tolerance of the oral appliance
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Efficacy on clinical symptoms
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Feasibility of this therapeutic method
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Identification of predictive factors of efficacy
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Secondary ID(s)
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2000/055/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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