SLEEP T2D TRIAL
Research type
Research Study
Full title
The Impact of Sleep Disorders in Patients with Type 2 Diabetes: A Cohort Study and Feasibility RCT
IRAS ID
236540
Contact name
Abd Tahrani
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
Type 2 diabetes (T2D) is very common and has a huge burden on patients, carers, and the NHS. Much of the burden of T2D is due to blockages in the small blood vessels leading to eye, kidney, nerve and foot problems.
Around two thirds of patients with T2D also have obstructive sleep apnoea (OSA). OSA is a condition where there are episodes of complete or partial blockage to the windpipe during sleep. This causes a short reduction in breathing. Our group showed that OSA might contribute to small blood vessels disease in T2D. Hence, it is important to examine the impact of OSA treatment on diabetes-related blood vessels disease.
In this project, we will assess the feasibility of conducting a study assessing the impact of OSA treatment on diabetes-related blood vessels disease. Our results could help identify new treatment targets that will reduce the burden of T2D.
We will register up to 500 patients with T2D into a observational cohort study. At baseline all participants will receive a sleep assessment to identify OSA.
If they consent to it, those participants with OSA will then be randomised (i.e. allocated treatment by chance like tossing a coin) to either receive OSA treatment or not. OSA treatment is called continuous positive airway pressure (CPAP), which is a device that delivers pressure to the upper wind pipes (via a mask worn on the face) to prevent the wind pipes from collapsing during sleep.
Both registered participants and the randomised subset of participants will remain in the study for 2 years. Patients will have clinical assessments related to diabetes, diabetes-related complications and sleep disorders at baseline and at study end (2 years from baseline). Patients will also receive 6 monthly phone calls.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0070
Date of REC Opinion
23 May 2018
REC opinion
Further Information Favourable Opinion