Title: Investigation of the effects of Montelukast on processing speed and executive functioning in young children with sleep disordered breathing and sickle cell anaemia
Funder: Action Medical Research

Abstract: Background_x000D_ Sickle cell disease (SCD) is the most common genetic disorder in the UK. Each year, about 300,000 babies with SCD are born worldwide. In the UK, SCD affects around one in 2,000 babies leading to 400 to 450 new cases each year. Patients with SCD have abnormal red blood cells that do not efficiently transport oxygen and children can have a range of difficulties such as anaemia, low oxygen levels and pain. These children are at high risk of stroke, but even without stroke, they can develop problems with thinking and switching attention. Children with SCD are more likely to snore and have abnormal breathing during sleep, a condition known as sleep apnoea.. The exact cause of this is not clear, but it may be related to enlarged adenoids and tonsils often found in children with SCD. When normal breathing is interrupted during sleep, blood oxygen levels fall causing the child to wake briefly and start breathing properly again. This can happen many times a night leading to severely disturbed sleep. Untreated sleep apnoea can affect a child's ability to concentrate during the day. Children can develop learning difficulties and may have particular problems with paying attention and impulse control. This is especially significant for children with SCD, who are already at risk of not achieving their full potential at school._x000D_ _x000D_ _x000D_ The research project_x000D_ _x000D_ These researchers will look at the effects of Montelukast, a drug widely used for asthma in young children, on sleep apnoea and associated learning difficulties in children with SCD. They will conduct a randomised controlled trial in up to 180 children aged between three and eight years. The study will investigate the impact of Montelukast on thinking speed and other complex brain functions such as planning, paying attention, memory and impulse control, in young children with sleep apnoea and/or SCD. The children will perform standardised tests made available on an iPad to assess how well their brain copes with a variety of complex tasks. The impact of treatment on sleep and asthma symptoms will be assessed through questionnaire and overnight oxygen studies. The team will also carry out magnetic resonance imaging brain scans to see if the treatment has any effect on adenoid size in the nose or on structures within the brain. Currently, adopting a 'wait and see' method or carrying out operations (such as removing tonsils and/or adenoids) are the only available treatment options for sleep apnoea in young children with SCD. This study will provide evidence on an alternative early treatment option which could improve overall health and learning abilities in a group of children faced with significant lifelong health concerns._x000D_

Lay abstract: Background_x000D_ Sickle cell disease (SCD) is the most common genetic disorder in the UK. Each year, about 300,000 babies with SCD are born worldwide. In the UK, SCD affects around one in 2,000 babies leading to 400 to 450 new cases each year. Patients with SCD have abnormal red blood cells that do not efficiently transport oxygen and children can have a range of difficulties such as anaemia, low oxygen levels and pain. These children are at high risk of stroke, but even without stroke, they can develop problems with thinking and switching attention. Children with SCD are more likely to snore and have abnormal breathing during sleep, a condition known as sleep apnoea.. The exact cause of this is not clear, but it may be related to enlarged adenoids and tonsils often found in children with SCD. When normal breathing is interrupted during sleep, blood oxygen levels fall causing the child to wake briefly and start breathing properly again. This can happen many times a night leading to severely disturbed sleep. Untreated sleep apnoea can affect a child's ability to concentrate during the day. Children can develop learning difficulties and may have particular problems with paying attention and impulse control. This is especially significant for children with SCD, who are already at risk of not achieving their full potential at school._x000D_ _x000D_ _x000D_ The research project_x000D_ _x000D_ These researchers will look at the effects of Montelukast, a drug widely used for asthma in young children, on sleep apnoea and associated learning difficulties in children with SCD. They will conduct a randomised controlled trial in up to 180 children aged between three and eight years. The study will investigate the impact of Montelukast on thinking speed and other complex brain functions such as planning, paying attention, memory and impulse control, in young children with sleep apnoea and/or SCD. The children will perform standardised tests made available on an iPad to assess how well their brain copes with a variety of complex tasks. The impact of treatment on sleep and asthma symptoms will be assessed through questionnaire and overnight oxygen studies. The team will also carry out magnetic resonance imaging brain scans to see if the treatment has any effect on adenoid size in the nose or on structures within the brain. Currently, adopting a 'wait and see' method or carrying out operations (such as removing tonsils and/or adenoids) are the only available treatment options for sleep apnoea in young children with SCD. This study will provide evidence on an alternative early treatment option which could improve overall health and learning abilities in a group of children faced with significant lifelong health concerns._x000D_

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INFECTION;NEUROLOGICAL