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| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | October 27, 2005 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00152672 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance | ||||
| Official Title ICMJE | Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial | ||||
| Brief Summary | This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Sleep Apnea Syndrome | ||||
| Intervention ICMJE | Device: nCPAP vs oral appliance | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 18 to 70 years old BMI < 35 kg/m2 Apnea-hypopnea index between 10 and 60 events/h Complaint of snoring and sleepiness Dental status adequate for treatment with oral appliance informed consent Exclusion Criteria: psychiatric disease professional driver other cause of sleepiness |
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| Gender | Male | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00152672 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | PHRC 04-10 | ||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | February 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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