Obstructive Sleep ApnoeaNCT01619748
Peripheral Vascular Function in Obstructive Sleep Apnoea
An observational study of Obstructive Sleep Apnoea and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Obesity
- How many people
- 45 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and controls living in and around Sheffield, UK
Who may be able to join
- Obstructive sleep apnoea diagnosed using overnight polysomnography
- Age 18-90 years
Who cannot join
- Unable to perform the tests involved in the study
- Unable to provide written informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, S102BP
Sheffield Teaching Hospitals NHS FT
Sheffield, South Yorkshire
About this study
Official title: Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function
Peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls.
Read the 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.
- Conditions
- Obstructive Sleep Apnoea, Obesity
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline only
Secondary outcomes (3)
GTN-mediated dilatation of the brachial artery
The brachial artery vasodilator response to a 400 microgram sublingual dose of glyceryl trinitrate will be measured using vascular ultrasound imaging.
Measured: Baseline only
Forearm skin blood flow response to 5-min proximal-cuff arterial occlusion
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.
Measured: Baseline only
Forearm skin blood flow response to localised heating at 42 degrees C
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.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Garry A Tew, PhD, Study director, Sheffield Hallam UniversityJames Moss, BSc, Principal investigator, Sheffield Hallam UniversityStephen Bianchi, MD, Study director, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619748
- Sponsor's protocol ID
- STH-16309
- Status last verified
- Aug 2013
- First submitted
- 8 Jun 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Obstructive Sleep Apnoea and Its Treatment on Macrovascular and Microvascular Function
- ClinicalTrials.gov ID
- NCT01619748
- Acronym / sponsor ID
- STH-16309
- Conditions
- Obstructive Sleep Apnoea, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and controls living in and around Sheffield, UK
Key inclusion criteria (2 listed)
- Obstructive sleep apnoea diagnosed using overnight polysomnography
- Age 18-90 years
Key exclusion criteria (2 listed)
- Unable to perform the tests involved in the study
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
GTN-mediated dilatation of the brachial artery
Time frame: Baseline only
Forearm skin blood flow response to 5-min proximal-cuff arterial occlusion
Time frame: Baseline only
Forearm skin blood flow response to localised heating at 42 degrees C
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Related trials for Obstructive Sleep Apnoea
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Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
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Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
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Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry A Tew, PhD study director
Sheffield Hallam University
James Moss, BSc principal investigator
Sheffield Hallam University
Stephen Bianchi, MD study director
Sheffield Teaching Hospitals NHS FT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea and Obesity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilatation of the brachial artery (time frame: Baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.