Obstructive Sleep ApnoeaNCT02518633
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction
An observational study of Obstructive Sleep Apnoea and Obesity, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Obesity, Hypoxia
- What is being tested?
- Continuous positive airway pressure devices
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2010to Nov 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with newly diagnosed obstructive sleep apnoea and controls
Who may be able to join
- men with or without obstructive sleep apnoea
Who cannot join
- weight loss interventions
- steroid use
- active smoking
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NIHR Clinical Research Facility
Exeter, EX25DW
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX25DW
About this study
Official title: Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea
Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.
Read the detailed description
Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.
- Conditions
- Obstructive Sleep Apnoea, Obesity, Hypoxia
- Being tested
- Continuous positive airway pressure devices
- Keywords
- obesity, hypoxia, adipose tissue
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure devicesDevice
Also called CPAP
overnight use of CPAP device
| Study group | Role | What they receive |
|---|---|---|
| men with obstructive sleep apnoea | Continuous positive airway pressure devices Receives: Device: Continuous positive airway pressure devices | |
| control subjects | subjects with no obstructive sleep apnoea |
What is being measured
The primary outcome is the main question the study is designed to answer.
pO2 in adipose tissue by Clarke type electrode
Measurement of pO2 by Clarke type electrode
Measured: 4 months
Secondary outcomes (1)
blood flow in adipose tissue by laser Doppler techniques
assessment of tissue blood flow by laser Doppler techniques
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMar 2010
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Principal investigator, Katarina Kos, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Katarina Kos, FRCP,PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518633
- Sponsor's protocol ID
- OSAadipose
- Status last verified
- Feb 2017
- First submitted
- 23 Mar 2015
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thorn CE, Knight B, Pastel E, McCulloch LJ, Patel B, Shore AC, Kos K. Adipose tissue is influenced by hypoxia of obstructive sleep apnea syndrome independent of obesity. Diabetes Metab. 2017 Jun;43(3):240-247. doi: 10.1016/j.diabet.2016.12.002. Epub 2017 Jan 26.
PubMed 28131740
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02518633
- Acronym / sponsor ID
- OSAadipose
- Conditions
- Obstructive Sleep Apnoea, Obesity, Hypoxia
- Keywords
- obesity, hypoxia, adipose tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Aug 2015 (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.
Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.
Detailed description
Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| men with obstructive sleep apnoea | – | Device: Continuous positive airway pressure devicesContinuous positive airway pressure devices |
| control subjects | – | –subjects with no obstructive sleep apnoea |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with newly diagnosed obstructive sleep apnoea and controls
Key inclusion criteria (1 listed)
- men with or without obstructive sleep apnoea
Key exclusion criteria (3 listed)
- weight loss interventions
- steroid use
- active smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure devicesAlso: CPAPovernight use of CPAP device | Device | men with obstructive sleep apnoea |
Primary outcome
pO2 in adipose tissue by Clarke type electrode
Time frame: 4 months
Measurement of pO2 by Clarke type electrode
1 secondary outcome
blood flow in adipose tissue by laser Doppler techniques
Time frame: 4 months
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 17 Feb 2017.
- Background: PubMed 28131740Thorn CE, Knight B, Pastel E, McCulloch LJ, Patel B, Shore AC, Kos K. Adipose tissue is influenced by hypoxia of obstructive sleep apnea syndrome independent of obesity. Diabetes Metab. 2017 Jun;43(3):240-247. doi: 10.1016/j.diabet.2016.12.002. Epub 2017 Jan 26.
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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.
Katarina Kos, FRCP,PhD principal investigator
University of Exeter
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 Royal Devon and Exeter 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 1 inclusion and 3 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 17 Feb 2017. 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?
pO2 in adipose tissue by Clarke type electrode (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518633, which also lists 1 linked publication.
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 17 Feb 2017.