Peripheral Vascular Function in Obstructive Sleep Apnoea
Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function
1 other identifier
observational
45
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 7, 2013
August 1, 2013
10 months
June 8, 2012
August 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilatation of the brachial artery
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.
Baseline only
Secondary Outcomes (3)
GTN-mediated dilatation of the brachial artery
Baseline only
Forearm skin blood flow response to 5-min proximal-cuff arterial occlusion
Baseline only
Forearm skin blood flow response to localised heating at 42 degrees C
Baseline only
Study Arms (4)
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
Eligibility Criteria
Patients and controls living in and around Sheffield, UK
You may qualify if:
- Obstructive sleep apnoea diagnosed using overnight polysomnography
- Age 18-90 years
You may not qualify if:
- Unable to perform the tests involved in the study
- Unable to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, S102BP, United Kingdom
Sheffield Teaching Hospitals NHS FT
Sheffield, South Yorkshire, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 14, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
August 7, 2013
Record last verified: 2013-08