Inflammation Clinical Trial
— INcOSAOfficial title:
Investigating the Neuropathology of Obstructive Sleep Apnoea
NCT number | NCT02967536 |
Other study ID # | 170912 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | September 9, 2019 |
Verified date | October 2019 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | September 9, 2019 |
Est. primary completion date | September 9, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
INCLUSION CRITERIA: 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 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 EXCLUSION CRITERIA: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's Hospital Sleep Centre | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | |
Primary | Cognitive performance using the CANTAB battery. | 27 participants, 9 healthy controls, 9 mild patients & 9 severe patients. | 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 | 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. | 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 |
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