None listed
Conditions
Brief summary
Snoring and mild sleep disordered breathing (SDB) are a common consequence of increased upper airway resistance during sleep. Habitual snoring (every night or almost every night) without overt obstructive sleep apnoea hypopnoea syndrome (OSAHS) is common in the community. Increasingly it is recognized that snoring and mild SDB are not just an annoying social problem but may pose real risks to health. Emerging research is highly suggestive of an independent role in the occurence of hypertension, stroke, coronary and carotid atherosclosis. The aim of this study is to further explore the linkage between heavy snoring with mild SDB and early carotid artery atherosclerosis by looking for regression or stabilisation of early changes of carotid atherosclerosis in heavy snorers with mild non-hypoxic SDB when snoring and SDB are prevented by the use of nasal continuous positive airway pressure (CPAP).
Interventions
Subjects are intially subdivided into drug and non drug use with regards to maintenance of their lipid/blood sugar stability. This will allow us to more easily monitor any differences in these two groups should they occur. Patients are then randomised to treatment i.e. continuous positive airway pressure (CPAP) or non treatment (no CPAP). CPAP will be used during sleep where possible throughout the trial period (approximately 12 months) once randomised to tthe CPAP group. All subjects will be r
Subjects are intially subdivided into drug and non drug use with regards to maintenance of their lipid/blood sugar stability. This will allow us to more easily monitor any differences in these two groups should they occur. Patients are then randomised to treatment i.e. continuous positive airway pressure (CPAP) or non treatment (no CPAP). CPAP will be used during sleep where possible throughout the trial period (approximately 12 months) once randomised to tthe CPAP group. All subjects will be reviewed with a monthly health maintenance questionnaire for the 12 month duration of the trial. Ultrasound, lipid and fasting blood sugar testing will be carried out at screening, 3 , 6 , 9 and 12 months (trial conclusion). CPAP group will have hours of use monitored at monthly intervals throughout the trial following an intial acclimatisation period which will have several follow ups in a week, if required, to help the patient settle to the treatment. Monthly follow ups maybe phone/face to face excluding the 3, 6, 9 and 12 month visit which will be face to face.
Sponsors
Professor John Wheatley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
46 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
Snoring greater than 50% of total sleep time (TST) Apnea hypopnea index (AHI) <30 events per hour and oxygen desaturation index of < 5 events per hour Normal fasting bloods for lipid profile and blood sugar level Non smoker or not smoked in the past year
Exclusion criteria
History of stroke History of diabetes History of clinically severe nasal or sinus disease History of carotid artery surgery
Outcome results
None listed