Improving sleep and reducing sedentary behavior in people with Type 2 diabetes
An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
NA · University of Leicester · NCT06471634
This study is testing whether a program that includes therapy for sleep issues and support for being more active can help people with Type 2 diabetes sleep better and move more.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06471634 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of improving sleep quality and reducing sedentary behavior in individuals diagnosed with Type 2 diabetes mellitus who experience sleep problems. Participants will be divided into an intervention group, which will receive cognitive behavioral therapy for insomnia (CBTi) and behavior change techniques, and a control group receiving usual care. The study will measure changes in objectively assessed sleep and sedentary behavior, as well as various physical and physiological markers, over the course of the intervention. Regular meetings with a qualified coach will support participants in achieving these goals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of Type 2 diabetes for more than three months and experiencing insomnia symptoms.
Not a fit: Patients with high risk of undiagnosed obstructive sleep apnea or those who are highly active with more than 75 minutes of strenuous exercise per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced sedentary behavior, enhancing the overall health and well-being of patients with Type 2 diabetes.
How similar studies have performed: Other studies have shown promising results using cognitive behavioral therapy for insomnia in various populations, suggesting potential success for this approach in individuals with Type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Individuals living with narcolepsy or diagnosed parasomnia * Individuals with type 1 diabetes or gestational diabetes * Recent cardiovascular event (within the last 6 months). * Currently on opioids * Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported). * Individuals living with epilepsy or seizures. * Shift workers * Female participant planning to become pregnant with the timeframe of the study or is currently pregnant. * Terminal illness.
Where this trial is running
Leicester, Leicestershire
- Diabetes Research Centre University Hospitals Leicester — Leicester, Leicestershire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Melanie Davies, PhD — Leicester Diabetes Centre
- Study coordinator: Alix HA Covenant, MSc
- Email: ahac1@leicester.ac.uk
- Phone: 01162588572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Insomnia, Sedentary Behavior, Sleep, Sedentary behaviour, Cognitive Behaviour Therapy insomnia, Behaviour change