We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01426607
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome Device: AMO

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Study Start Date : March 2011
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AMO
Adjustable mandibular repositioning appliance
Device: AMO
Placebo Comparator: placebo
placebo device in upper jaw
Device: AMO


Outcome Measures

Primary Outcome Measures :
  1. change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. change from baseline to 2-months in markers of OSA severity [ Time Frame: 2 months ]
  2. change from baseline to 2-months in blood pressure [ Time Frame: 2 months ]
  3. change from baseline to 2-months in symptoms of OSA [ Time Frame: 2 months ]
  4. evaluate treatment compliance objectively measured by an embedded micro sensor [ Time Frame: 15 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426607


Locations
France
CHU Grenoble
Grenoble, France, 38100
CH Le Mans
Le Mans, France, 72100
Hopital Saint Antoine
Paris, France, 75012
CHU Poitiers
Poitiers, France, 86000
Sponsors and Collaborators
University Hospital, Angers
More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01426607     History of Changes
Other Study ID Numbers: PHRC 2010-06
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: August 2011

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 Wake Disorders
Nervous System Diseases