Peripheral Vascular Function in Obstructive Sleep Apnoea

Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01619748
Collaborator
Sheffield Hallam University (Other)
45
2
12
22.5
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Untreated OSA patients

    Patients with obstructive sleep apnoea who are untreated

    OSA patients highly compliant with CPAP

    OSA patients established on CPAP therapy (high compliance, > 80% nightly use for ≥ 4 h per night)

    OSA patients poorly compliant with CPAP

    OSA patients established on CPAP therapy (poor compliance, 10% < nightly use < 50% or < 4 h per night)

    Age and BMI-matched controls

    Age and BMI-matched controls without OSA

    Outcome Measures

    Primary Outcome Measures

    1. Flow-mediated dilatation of the brachial artery [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 Outcome Measures

    1. GTN-mediated dilatation of the brachial artery [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Sport and Exercise Science, Sheffield Hallam University Sheffield South Yorkshire United Kingdom S102BP
    2 Sheffield Teaching Hospitals NHS FT Sheffield South Yorkshire United Kingdom

    Sponsors and Collaborators

    • Sheffield Teaching Hospitals NHS Foundation Trust
    • Sheffield Hallam University

    Investigators

    • Study Director: Garry A Tew, PhD, Sheffield Hallam University
    • Principal Investigator: James Moss, BSc, Sheffield Hallam University
    • Study Director: Stephen Bianchi, MD, Sheffield Teaching Hospitals NHS FT

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheffield Teaching Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT01619748
    Other Study ID Numbers:
    • STH-16309
    First Posted:
    Jun 14, 2012
    Last Update Posted:
    Aug 7, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2013