A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Leicester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CBTi
BehavioralA 12 week intervention using CBTi to improve sleep measured using objective and subjective measures. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Control - usual care
Other interventionParticipants will be given a leaflet summarising good sleep practice and the advantages of reducing sedentary behaviour. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Sedentary behaviour reduction
BehavioralParticipants will be encouraged to increase activity and thus reduce sedentary time. Investigators will use behaviour change techniques to aid in this goal. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: CBTi and Sedentary Behaviour supportExperimental treatment 2 interventions
Group B: Control - usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Efficiency (SE) measured using accelerometer data.
The primary outcome measure is change in objectively measured SE in the intervention arm compared to the control group.
Time frame
Before and after the 12 week intervention/intervention periodSecondary outcomes
1
Objectively measured sleep - sleep onset latency
Accelerometer data will be used to measure sleep onset latency in minutes.
Time frame
Before and after the 12 week intervention/intervention period2
Objectively measured sleep - wake after sleep onset
Accelerometer data will be used to measure wake after sleep onset in minutes.
Time frame
Before and after the 12 week intervention/intervention period3
Objectively measured sleep - total sleep time
Accelerometer data will be used to measure total sleep time in minutes.
Time frame
Before and after the 12 week intervention/intervention period4
Objectively measured sleep - sleep duration variability
Accelerometer data will be used to measure sleep duration variability in minutes.
Time frame
Before and after the 12 week intervention/intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
Source ClinicalTrials.gov