Extrait

Background and study aims Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, stopping the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. Previous research has shown that the low blood oxygen levels affect thinking and feeling, and in some cases it may damage the brain cells involved with memory, attention, emotions and decision-making (cognitive function). The aim of this study is to investigate the relationship between the amount of oxygen in the blood and the loss (if any) of brain cells, as well as how the ability to perform complex tasks is affected in patients that suffer from sleep apnoea. Who can participate? Adult men with untreated mild OSA who are experience excessive sleepiness. What does the study involve? At the start of the study, participants are interviewed, provide blood and saliva samples, have their cognitive function tested and have two MRI brain scans and two PET-MR brain scans. The MMRI scan involves going into an MRI scanner (large tube) which uses strong magnetic fields and radiowaves to see the activity in the brain. The PET-MR scan is a MRI scanning is combined with another type of scanning called PET, which involves the injection of a radioactive tracer into the body which is picked up in the scan. Participants then return three months later after having been treated with CPAP as part of their normal care. At the three months visit, the initial tests are repeated in order to find out if the CPAP has caused any structural changes in the brain or affected cognitive function. What are the possible benefits and risks of participating? There are no direct benefits of taking part, however some participants may find taking part in research rewarding, as they will be contributing to the development of medical knowledge that may benefit other people in the future. The main disadvantage of taking part in this study is the extra time taken to attend the hospital for the tests. Participants will be assisted with travel arrangements to attend the tests. Some private medical insurers require to be notified of participation in research studies. The interview involves discussing personal information and experiences that some people may find distressing. Participants will be informed that if they feel uncomfortable with any of the questions they do not have to answer them. Blood sampling can cause some discomfort, and there is a possibility that a small bruise may develop. In addition, participants may find the MRI scan to be claustrophobic or anxiety-causing and the PET scan to be uncomfortable as it involves a line being placed in a vein, which can cause pain, bruising and infection. Where is the study run from? Nuffield House Sleep Centre (UK) When is the study starting and how long is it expected to run for? June 2016 to October 2020 Who is funding the study? Wellcome Trust (UK) Who is the main contact? Dr Nadia Gildeh [email protected]

Critère d'inclusion

• Specialty: Neurological disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Neurological/ Episodic and paroxysmal disorders

Liens

• isrctn