Obstructive Sleep ApnoeaINcOSANCT02967536
Investigating the Neuropathology of Obstructive Sleep Apnoea
An observational study of Obstructive Sleep Apnoea and Inflammation, run by King's College London at 1 site in United Kingdom.
Trial summary
Our multi-disciplinary research group works closely with people who have obstructive sleep apnoea. This is a life-long illness that causes breathing to stop during sleep, which leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the throat reopens, usually during arousal from sleep. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Inflammation
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 9 Sep 2019
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient group: * Untreated patients with mild Sleep Apnoea - Apnoea-Hypopnoea Index (AHI) >5 events/hour and <10 events/hour with excessive sleepiness (Epworth sleepiness score >9). * Untreated patients with severe Sleep Apnoea - AHI >30 events/hour with excessive sleepiness (Epworth sleepiness score >9). Healthy control group: * Male participants * No history of sleep disorders * AHI≤5/hour * No current or previous major neurological or psychiatric disease * Not currently undertaking neuropharmacological treatment * Non-smoker * No history of alcohol or recreational drug abuse, major organ failure * Not professional drivers or shift workers.
Who may be able to join
- Participants with OSA:
- Male patients
- With untreated OSA either mild (AHI≥5/hour and ≤10/hour)
- or severe (AHI≥30/hour)
- With excessive sleepiness (ESS≥9)
- Aged 18-69 years
Show all 16Show fewer
- Healthy control group:
- Male participants
- No history of sleep disorders
- AHI≤5/hour
- No current or previous major neurological or psychiatric disease
- Not currently undertaking neuropharmacological treatment
- Non-smoker
- No history of alcohol or recreational drug abuse
- No major organ failure
- Not professional drivers or shift workers
Who cannot join
- Having other sleep disorders, neurological or psychiatric disease
- Undertaking neuropharmacological treatment
- Has a history of alcohol or recreational drug abuse, major organ failure
- Professional drivers or shift workers
- Unable to have MR scan (e.g. too heavy (>200Kg) or have ferromagnetic implants)
- [18F]DPA-714 affinity too low
- Inability to comprehend what is proposed
- Inability to travel to the research sites
Trial locations and contacts
1 site in 1 country.
About this study
Our multi-disciplinary research group works closely with people who have obstructive sleep apnoea. This is a life-long illness that causes breathing to stop during sleep, which leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the throat reopens, usually during arousal from sleep. In some people the repeated arousals from sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels affect thinking and feeling, and in some cases we think it damages the brain cells involved with memory, attention, emotions and decision-making.
This study will investigate the relationship between the amount of oxygen in the blood and the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected in patients that suffer from sleep apnoea. The results will show whether the brain damage in patients with sleep apnoea can be reversed with treatment. These findings will guide doctors in the treatment for sleep apnoea and they will cast light onto the process of memory decline with the aim to preserve brain function.
Read the detailed description
This is a cross-sectional physiological study, which is anticipated to last for 4 years. In order to study the mechanism of cognitive dysfunction in Obstructive Sleep Apnoea (OSA), patients will start Continuous Positive Airway Pressure (CPAP) treatment following the confirmed diagnosis of sleep apnoea. CPAP is the treatment of choice for patients with moderate to severe OSA who are sleepy during the day. It is also used in patients with mild OSA if they are excessively sleepy or suffer from cardiovascular risk factors. It is recommended by the National Institute for Clinical Excellence (NICE) as a treatment for adults with moderate or severe OSA (Sleep apnoea - continuous positive airway pressure, NICE 2008). In the proposed study the initiation of CPAP will be within the 18 week period set out in the National Health Service (NHS) Improvement Plan and Standards for Better Health (Standards for Better Health, Department of Health 2004). No patient with a diagnosis of OSA will commence treatment with CPAP later than advised by the NICE guidelines of clinical judgement for the best interest of the patient.
In order to investigate the neuroinflammation process and discrete changes in the brain of patients with OSA, a minimum of 9 patients with mild OSA and 9 patients with severe OSA will be compared to 9 healthy controls following initial sleep (assessment) study. All participants will undergo a dynamic Positron Emission Tomography with Magnetic Resonance Imaging (PET-MR) scan with the Translocator protein (TSPO) tracer [Fluorine-18] N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide (DPA-714) at the time of enrolment to the study. Each participant will also have an MRI scan and cognitive testing.
- Conditions
- Obstructive Sleep Apnoea, Inflammation
- Keywords
- cognitive function, microglia, neuroinflammation
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation, Neuroinflammatory Diseases
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 |
|---|---|---|
| Mild OSA | Untreated OSA patients. Apnoea-Hypopnoea Index (AHI) >5 events/hour and <10 events/hour with Epworth Sleepiness Score (ESS)>9. | |
| Severe OSA | Untreated OSA patients. AHI >30 events/hour, with excessive sleepiness (ESS >9). | |
| Healthy control | Healthy control. AHI <5 events/hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG.
27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.
Measured: MRI, PET-MRI & EEG data analyses will begin right after the completion of data collection, and the summary of results will be reported as soon as available, expected before the completion date of the study as per IRAS 01/06/2020.
Cognitive performance using the CANTAB battery.
27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.
Measured: Cognitive performance data analyses will be conducted after the completion of data collection, and the summary of results will be reported along the rest of results in the summary that will be published before 01/06/2020.
Secondary outcomes (1)
Genetic analysis and linkage to clinical and neuroimaging data will be measured using biological samples (blood or saliva) analysed and stored in the BioResource for Mental and Neurological Health.
18 patients, 9 mild \& 9 severe.
Measured: Genetic analysis and linkage to clinical and neuroimaging data analyses are expected to continue after the end of the primary study and they will be independently reported by the BioResource for Mental and Neurological Health KCL, within 5 years of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start1 Nov 2017
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
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.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ivana Rosenzweig, MD, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967536
- Sponsor's protocol ID
- 170912
- Acronym
- INcOSA
- Status last verified
- Oct 2019
- First submitted
- 17 Aug 2016
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neuropathology of Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02967536
- Acronym / sponsor ID
- INcOSA / 170912
- Conditions
- Obstructive Sleep Apnoea, Inflammation
- Keywords
- cognitive function, microglia, neuroinflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 18 Nov 2016 (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.
Our multi-disciplinary research group works closely with people who have obstructive sleep apnoea. This is a life-long illness that causes breathing to stop during sleep, which leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the throat reopens, usually during arousal from sleep. In some people the repeated arousals from sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels affect thinking and feeling, and in some cases we think it damages the brain cells involved with memory, attention, emotions and decision-making.
This study will investigate the relationship between the amount of oxygen in the blood and the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected in patients that suffer from sleep apnoea. The results will show whether the brain damage in patients with sleep apnoea can be reversed with treatment. These findings will guide doctors in the treatment for sleep apnoea and they will cast light onto the process of memory decline with the aim to preserve brain function.
Detailed description
This is a cross-sectional physiological study, which is anticipated to last for 4 years. In order to study the mechanism of cognitive dysfunction in Obstructive Sleep Apnoea (OSA), patients will start Continuous Positive Airway Pressure (CPAP) treatment following the confirmed diagnosis of sleep apnoea. CPAP is the treatment of choice for patients with moderate to severe OSA who are sleepy during the day. It is also used in patients with mild OSA if they are excessively sleepy or suffer from cardiovascular risk factors. It is recommended by the National Institute for Clinical Excellence (NICE) as a treatment for adults with moderate or severe OSA (Sleep apnoea - continuous positive airway pressure, NICE 2008). In the proposed study the initiation of CPAP will be within the 18 week period set out in the National Health Service (NHS) Improvement Plan and Standards for Better Health (Standards for Better Health, Department of Health 2004). No patient with a diagnosis of OSA will commence treatment with CPAP later than advised by the NICE guidelines of clinical judgement for the best interest of the patient.
In order to investigate the neuroinflammation process and discrete changes in the brain of patients with OSA, a minimum of 9 patients with mild OSA and 9 patients with severe OSA will be compared to 9 healthy controls following initial sleep (assessment) study. All participants will undergo a dynamic Positron Emission Tomography with Magnetic Resonance Imaging (PET-MR) scan with the Translocator protein (TSPO) tracer [Fluorine-18] N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide (DPA-714) at the time of enrolment to the study. Each participant will also have an MRI scan and cognitive testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild OSA | – | –Untreated OSA patients. Apnoea-Hypopnoea Index (AHI) >5 events/hour and <10 events/hour with Epworth Sleepiness Score (ESS)>9. |
| Severe OSA | – | –Untreated OSA patients. AHI >30 events/hour, with excessive sleepiness (ESS >9). |
| Healthy control | – | –Healthy control. AHI <5 events/hour. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient group: * Untreated patients with mild Sleep Apnoea - Apnoea-Hypopnoea Index (AHI) >5 events/hour and <10 events/hour with excessive sleepiness (Epworth sleepiness score >9). * Untreated patients with severe Sleep Apnoea - AHI >30 events/hour with excessive sleepiness (Epworth sleepiness score >9). Healthy control group: * Male participants * No history of sleep disorders * AHI≤5/hour * No current or previous major neurological or psychiatric disease * Not currently undertaking neuropharmacological treatment * Non-smoker * No history of alcohol or recreational drug abuse, major organ failure * Not professional drivers or shift workers.
Key inclusion criteria (16 listed)
- Male patients
- With untreated OSA either mild (AHI≥5/hour and ≤10/hour)
- or severe (AHI≥30/hour)
- With excessive sleepiness (ESS≥9)
- Aged 18-69 years
Key exclusion criteria (8 listed)
- Having other sleep disorders, neurological or psychiatric disease
- Undertaking neuropharmacological treatment
- Has a history of alcohol or recreational drug abuse, major organ failure
- Professional drivers or shift workers
- Unable to have MR scan (e.g. too heavy (>200Kg) or have ferromagnetic implants)
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
Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG.
Time frame: MRI, PET-MRI & EEG data analyses will begin right after the completion of data collection, and the summary of results will be reported as soon as available, expected before the completion date of the study as per IRAS 01/06/2020.
27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.
Cognitive performance using the CANTAB battery.
Time frame: Cognitive performance data analyses will be conducted after the completion of data collection, and the summary of results will be reported along the rest of results in the summary that will be published before 01/06/2020.
27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.
1 secondary outcome
Genetic analysis and linkage to clinical and neuroimaging data will be measured using biological samples (blood or saliva) analysed and stored in the BioResource for Mental and Neurological Health.
Time frame: Genetic analysis and linkage to clinical and neuroimaging data analyses are expected to continue after the end of the primary study and they will be independently reported by the BioResource for Mental and Neurological Health KCL, within 5 years of study
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 10 Oct 2019.
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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.
Ivana Rosenzweig, MD, PhD principal investigator
King's College London
1 site 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 Inflammation, run by King's College London at 1 site 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 16 inclusion and 8 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG. (time frame: MRI, PET-MRI & EEG data analyses will begin right after the completion of data collection, and the summary of results will be reported as soon as available, expected before the completion date of the study as per IRAS 01/06/2020.). The study lists 2 primary outcomes in all. 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 10 Oct 2019.