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Peripheral Vascular Function in Obstructive Sleep Apnoea

NCT ID: NCT01619748

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnoea Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Untreated OSA patients

Patients with obstructive sleep apnoea who are untreated

No interventions assigned to this group

OSA patients highly compliant with CPAP

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

No interventions assigned to this group

OSA patients poorly compliant with CPAP

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

No interventions assigned to this group

Age and BMI-matched controls

Age and BMI-matched controls without OSA

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheffield Hallam University

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Garry A Tew, PhD

Role: STUDY_DIRECTOR

Sheffield Hallam University

James Moss, BSc

Role: PRINCIPAL_INVESTIGATOR

Sheffield Hallam University

Stephen Bianchi, MD

Role: STUDY_DIRECTOR

Sheffield Teaching Hospitals NHS FT

Locations

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Centre for Sport and Exercise Science, Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Site Status

Sheffield Teaching Hospitals NHS FT

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH-16309

Identifier Type: -

Identifier Source: org_study_id