The impact of sleep disorders in patients with type 2 diabetes: a cohort study and feasibility randomised controlled trial

niversity of Birmingham0 个研究点目标入组 312 人开始时间: 2018年4月10日最近更新: 2024年2月19日

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33752759/ (added 23/08/2022) 2024 Results article in https://doi.org/10.5664/jcsm.11020 (added 07/02/2024)

•Potential participants will be considered eligible for registration into the study if they:
•1. Are =18 years old
•2. Have Type 2 Diabetes
•3. Have an eGFR (MDRD-4) =15 mL/min/1.73 m2 in last 3 months
•4. Have an ESS <11
•Potential participants will be considered eligible for randomisation into the RCT if the patient:
•1. Is willing to be randomised to CPAP or no CPAP
•2. Has a AHI =10

•Potential participants will be excluded from the study if they:
•1. Have Type 1 diabetes
•2. Have known OSA, active malignancy or chronic kidney disease from reasons other than diabetes
•3. Are receiving chemotherapy, immunosuppressant drugs or home oxygen treatment
•4. Have a history of recurrent hospital admissions due to infective exacerbation of a respiratory condition
•5. Have received contrast imaging within the last two months
•6. Are pregnant
•7. Are intending to undergo bariatric surgery during the study duration
•8. Are unable to comply with the study protocol
•9. Are unable to give informed consent
•10. Are a professional driver, operator of heavy machinery and/or working at high altitude
•11. Have a history of falling asleep whilst driving within last two years
•After the home-based sleep study, potential participants will be excluded from the RCT if they:
•1. Have a resting oxygen saturation < 90% (as detected during the sleep assessment recording) or have central apnoeas > 5/ hour

发起方