An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Diabetes Research Centre University Hospitals Leicester
RECRUITING
Leicester
Contact Information
Primary
Alix HA Covenant, MSc
ahac1@leicester.ac.uk
01162588572
Backup
Joe Henson, PhD
jjh18@leicester.ac.uk
1162588572
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-07
Participants
Target number of participants: 44
Treatments
Experimental: CBTi and Sedentary Behaviour support
Participants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques.
Active_comparator: Control - usual care
Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour.
Related Therapeutic Areas
Sponsors
Leads: University of Leicester
Collaborators: University Hospitals, Leicester

This content was sourced from clinicaltrials.gov