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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AMO
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble
  • CH Le Mans
  • Hopital Saint Antoine
  • CHU Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMO

placebo

Arm Description

Adjustable mandibular repositioning appliance

placebo device in upper jaw

Outcomes

Primary Outcome Measures

change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.

Secondary Outcome Measures

change from baseline to 2-months in markers of OSA severity
change from baseline to 2-months in blood pressure
change from baseline to 2-months in symptoms of OSA
evaluate treatment compliance objectively measured by an embedded micro sensor

Full Information

First Posted
June 28, 2011
Last Updated
December 12, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01426607
Brief Title
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Acronym
VASO-AM
Official Title
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMO
Arm Type
Experimental
Arm Description
Adjustable mandibular repositioning appliance
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo device in upper jaw
Intervention Type
Device
Intervention Name(s)
AMO
Primary Outcome Measure Information:
Title
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
change from baseline to 2-months in markers of OSA severity
Time Frame
2 months
Title
change from baseline to 2-months in blood pressure
Time Frame
2 months
Title
change from baseline to 2-months in symptoms of OSA
Time Frame
2 months
Title
evaluate treatment compliance objectively measured by an embedded micro sensor
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72100
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30366971
Citation
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.
Results Reference
derived
PubMed Identifier
28128967
Citation
Gagnadoux 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.
Results Reference
derived

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

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