VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
VASO-AM
1 other identifier
interventional
150
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedDecember 13, 2016
August 1, 2011
4 years
June 28, 2011
December 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
2 months
Secondary Outcomes (4)
change from baseline to 2-months in markers of OSA severity
2 months
change from baseline to 2-months in blood pressure
2 months
change from baseline to 2-months in symptoms of OSA
2 months
evaluate treatment compliance objectively measured by an embedded micro sensor
15 weeks
Study Arms (2)
AMO
EXPERIMENTALAdjustable mandibular repositioning appliance
placebo
PLACEBO COMPARATORplacebo device in upper jaw
Interventions
Eligibility Criteria
You may qualify if:
- AHI \> 30
- Intolerance to CPAP therapy
- Signed informed consent
You may not qualify if:
- Epworth sleepiness scale \> 16/24
- Severe cardiac and/or respiratory disease
- BMI\>32 kg/m2
- Dental contraindication to oral appliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Grenoble
Grenoble, 38100, France
CH Le Mans
Le Mans, 72100, France
Hopital Saint Antoine
Paris, 75012, France
CHU Poitiers
Poitiers, 86000, France
Related Publications (2)
Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.
PMID: 30366971DERIVEDGagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.
PMID: 28128967DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
August 31, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
December 13, 2016
Record last verified: 2011-08