NCT06471634Recruiting
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 10 Jun 2024
- Start date
- 2 Sept 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- University of Leicester
- Diseases
- Type 2 diabetes
- NCT number
- NCT06471634
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 2 Sept 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on opioids
Other illness
- Individuals with type 1 diabetes or gestational diabetes
- Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
- Individuals living with epilepsy or seizures.
- Terminal illness.
Other
- Individuals living with narcolepsy or diagnosed parasomnia
- Recent cardiovascular event (within the last 6 months).
- Shift workers
- Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
Who the study is looking for
- Diagnosed with Diabetes Mellitus type 2 for longer than 3 months
- Participant is willing and able to give informed consent to take part in the study.
- Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
- Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.
- Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
- Male or Females.
- ≥ 18 ≤ 75 years of age.
- Able to walk without the use of an assistive device or requiring assistance from another person.
- Not undertaking more than 75 minutes a week of strenuous exercise or sport.
- Not taking opioids
- Be treatment stable for at least 3 months
- Accelerometer measurement of SE ≤ 85%
- An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Diabetes Research Centre University Hospitals Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.