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Completed

NCT Number: NCT01426607

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMO

Device

Primary outcomes

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

    Time frame: 2 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: VASO-AM

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2011
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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