Actively Recruiting
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Led by University of Leicester · Updated on 2025-03-27
44
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.
CONDITIONS
Official Title
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 2 diabetes for longer than 3 months
- Willing and able to give informed consent
- Sleep disorder symptom checklist score of 5 or higher on insomnia criteria
- Not at high risk for undiagnosed obstructive sleep apnea (STOP BANG score less than 5) or treated for obstructive sleep apnea
- Glycated hemoglobin (HbA1c) of 10% (86 mmol/mol) or less
- Male or female aged between 18 and 75 years
- Able to walk without assistance or using an assistive device
- Not doing more than 75 minutes of strenuous exercise or sport per week
- Not taking opioids
- Stable treatment for at least 3 months
- Accelerometer measured sleep efficiency of 85% or less
- Understand that CBTi may temporarily worsen sleep deprivation affecting daily life
You will not qualify if you...
- Diagnosis of narcolepsy or parasomnia
- Diagnosis of type 1 diabetes or gestational diabetes
- Cardiovascular event within the last 6 months
- Currently taking opioids
- Diagnosis of borderline personality disorder, psychosis, adult ADHD, or schizophrenia
- Diagnosis of epilepsy or seizures
- Shift worker
- Female planning pregnancy during the study or currently pregnant
- Terminal illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Diabetes Research Centre University Hospitals Leicester
Leicester, Leicestershire, United Kingdom, LE5 4PW
Actively Recruiting
Research Team
A
Alix HA Covenant, MSc
CONTACT
J
Joe Henson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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