VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01426607
First received: June 28, 2011
Last updated: August 30, 2011
Last verified: August 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014