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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01426607
First received: June 28, 2011
Last updated: December 12, 2016
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:

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

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

Enrollment: 150
Study Start Date: March 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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   (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
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

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
Study First Received: June 28, 2011
Last Updated: December 12, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017