Digital Sleep Treatment for Metabolic Health (SleepTMH) study
Research type
Research Study
Full title
Sleep improvement for metabolic health: Feasibility trial of a digital sleep treatment in people who are at high risk of type 2 diabetes and have insomnia
IRAS ID
266313
Contact name
Simon Kyle
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN19682964
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Insomnia has been recognised as a risk factor for the development of type 2 diabetes and is also associated with poorer glycaemic control. We would like to test whether improving sleep can help improve metabolic health in people at high-risk of type 2 diabetes. This hypothesis would be best tested in a randomised controlled trial (RCT). Before undertaking a RCT we will conduct a small feasibility study (SleepTMH) to test the intervention and the recruitment process. The SleepTMH study will use a digital cognitive behavioural therapy (dCBT) as an intervention. Several RCTs have shown that dCBT improves sleep but the effect on metabolism has not yet been tested. Patients will be identified and recruited from primary care by searching patient records. After completing an eligibility assessment (online or over the phone), participants will then be invited to a baseline visit (visit 1). Here they will undergo detailed metabolic measurement testing, undertake a visual short-term memory test and complete the SleepTMH Baseline Questionnaire. They will also be provided with a continuous glucose monitor (CGM) and a wrist-worn activity monitor and asked to complete a SleepTMH Sleep Diary over the next 7 days. After 7 days (at visit 2) the monitors and diary will be collected. Participants will then be sent registration details for the online dCBT programme Sleepio. They will use Sleepio for the next 10 weeks before attending visit 3 where they will repeat the assessments taken at baseline. They will again be provided with the CGM, wrist-worn activity monitor and SleepTMH Sleep Diary for the next 7 days. The monitors and diary will again be collected after 7 days marking the final visit (visit 4) and the end of their study involvement. Each participant will take part for 12 weeks from the time of providing consent.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0046
Date of REC Opinion
12 Mar 2020
REC opinion
Further Information Favourable Opinion