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Completed

NCT Number: NCT01619748

Peripheral Vascular Function in Obstructive Sleep Apnoea

Peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls.

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Key information

Conditions

Obstructive Sleep Apnoea Apnea Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, South Yorkshire, United Kingdom

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About this study

Obstructive sleep apnoea (OSA) is a chronic respiratory disorder associated with endothelial dysfunction, increased sympathetic activation and increased cardiovascular risk. The standard treatment paradigm is continuous positive airway pressure (CPAP), however, patient adherence to CPAP is variable. It is unclear to what extent that poor adherence to CPAP therapy augments vascular endothelial function and reduces cardiovascular risk compared to excellent adherence. The main aim of this research is to investigate vascular endothelial function in OSA patients who are poorly-adherent to CPAP therapy. Nitric oxide (NO)-mediated, endothelium-dependent macrovascular and microvascular function (by brachial artery flow-mediated dilatation and forearm cutaneous thermal hyperaemia, respectively) and generalised microvascular function (by post-occlusion reactive hyperaemia) will be assessed in three obese OSA patient populations (high-adherence (n=20); low adherence (n=20); and, untreated (n=20)) and age-/BMI-matched OSA-free controls. We will also assess body composition, cardiovascular risk, lipid status and functional capacity. This research will evaluate treatment efficacy in patients who are poorly-adherent to CPAP treatment and could identify whether an alternative approach to their care should be explored.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Obstructive sleep apnoea diagnosed using overnight polysomnography
  • Age 18-90 years

Exclusion criteria

  • Unable to perform the tests involved in the study
  • Unable to provide written informed consent

Treatment and study plan

Primary outcomes

  1. Flow-mediated dilatation of the brachial artery

    Time frame: Baseline only

    The brachial artery dilator response to a 5-min period of forearm arterial occlusion will be measured using a vascular ultrasound scanner and a 7-MHz linear array probe.

Secondary outcomes

  1. GTN-mediated dilatation of the brachial artery

    Time frame: Baseline only

    The brachial artery vasodilator response to a 400 microgram sublingual dose of glyceryl trinitrate will be measured using vascular ultrasound imaging.

  2. Forearm skin blood flow response to 5-min proximal-cuff arterial occlusion

    Time frame: Baseline only

    Proximal arterial occlusion will be performed by inflating a blood pressure cuff placed on the upper arm to 200 mmHg for 5 min. After cuff deflation, the skin blood flow response will be measured using laser Doppler flowmetry.

  3. Forearm skin blood flow response to localised heating at 42 degrees C

    Time frame: Baseline only

    A local heating unit on the forearm will be heated from 33 to 42 degrees C at a rate of 1 degree C every 10 s. Temperature will be held at 42 degrees C for 35 min. The increase in skin blood flow will be measured using a laser Doppler flowmetry probe placed in the centre of the local heating unit.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University

Registry information

Official study title

Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2012
Registry last updated
Aug 7, 2013

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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