VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
This study is currently recruiting participants.
Verified August 2011 by University Hospital, Angers
Sponsor:
University Hospital, Angers
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01426607
First received: June 28, 2011
Last updated: August 30, 2011
Last verified: August 2011
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Purpose
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Syndrome |
Device: AMO |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea |
Resource links provided by NLM:
Further study details as provided by University Hospital, Angers:
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMO
Adjustable mandibular repositioning appliance
|
Device: AMO |
|
Placebo Comparator: placebo
placebo device in upper jaw
|
Device: AMO |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- AHI > 30
- Intolerance to CPAP therapy
- Signed informed consent
Exclusion Criteria:
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>32 kg/m2
- Dental contraindication to oral appliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426607
Contacts
| Contact: Frédéric Gagnadoux, MD PhD | (0)241353695 ext 0033 | frgagnadoux@chu-angers.fr |
Locations
| France | |
| CHU Grenoble | Recruiting |
| Grenoble, France, 38100 | |
| Contact: Jean Louis Pepin, PhD | |
| Principal Investigator: Jean Louis Pepin | |
| CH Le Mans | Recruiting |
| Le Mans, France, 72100 | |
| Contact: François Goupil fgoupil@ch-lemans.fr | |
| Principal Investigator: François Goupil, PhD | |
| Hopital Saint Antoine | Recruiting |
| Paris, France, 75012 | |
| Contact: Bernard Fleury, MD | |
| Principal Investigator: Bernard Fleury, MD | |
| CHU Poitiers | Recruiting |
| Poitiers, France, 86000 | |
| Contact: Jean Claude Meurice, PhD | |
| Principal Investigator: Jean Claude Meurice, PhD | |
Sponsors and Collaborators
University Hospital, Angers
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01426607 History of Changes |
| Other Study ID Numbers: | PHRC 2010-06 |
| Study First Received: | June 28, 2011 |
| Last Updated: | August 30, 2011 |
| Health Authority: | France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS) |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013