non-REm-Sleep inTervention to improvE Diabetes - RESTED

• Research type

  Research Study

• Full title

  non-REm Sleep inTervention to improvE Diabetes: A Feasibility Study

• IRAS ID

  251996

• Contact name

  Graham Law

• Contact email

  glaw@lincoln.ac.uk

• Sponsor organisation

  University of Lincoln

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Diabetes is a known risk factor for cardiovascular disease. Our research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of future cardiovascular events. We propose that improved sleep health will result in improved glucose levels in participants with T2DM.

  We plan to use short bursts of sound (pink noise) during sleep to improve the deep-sleep phase. The study will be a ‘crossover randomised controlled trial’ in which two different treatments (intervention and control) are compared in all participants.

  The study will be based at the University of Lincoln Sleep Laboratory. Participants will be recruited via local GP practices. Twenty five adults with T2DM who have normal sleeping patterns will be invited to attend the sleep laboratory on 3 nights, each visit separated by one week.

  The primary outcome measure for this study will be the difference in mean glucose between the intervention and control periods over the first 24 hours after waking.
  Participants will be fitted with sensors on their faces to measure muscle tone and eye-movements and scalps to measure brain activity (EEG) and earphones that will deliver the ‘pink noise’. The first night will be a ‘sham’ visit with no intervention, and nights 2 and 3 will be randomised to either intervention or control. An oral glucose tolerance test will be performed on the mornings of visits 2 and 3. During visits 2 and 3 participants will be fitted with a continuous glucose monitor which will be worn for 7 days.

  This is a feasibility study and the findings will be used to design a large randomised controlled trial. With the increasing prevalence of diabetes it is important to develop new approaches without the frequently observed side effects associated with pharmacological treatments to improve glucose control in patients with T2DM.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  19/EM/0001

• Date of REC Opinion

  12 Feb 2019

• REC opinion

  Further Information Favourable Opinion