An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Leicester
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Sleep Efficiency (SE) measured using accelerometer data.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The technicians analysing the accelerometer data and blood analysis will be blinded as to which arm the participant is from, no other masking is possible.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Sedentary behaviour reduction (Behavioral)
Control - usual care
Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour.
Intervention: Control - usual care (Other)
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.
Intervention: CBTi (Behavioral)
Outcomes
Primary Outcomes
Sleep Efficiency (SE) measured using accelerometer data.
Time Frame: Before and after the 12 week intervention/intervention period
The primary outcome measure is change in objectively measured SE in the intervention arm compared to the control group.
Secondary Outcomes
- Measurement of fatigue(Before and after the 12 week intervention/intervention period)
- Blood pressure(Before and after the 12 week intervention/intervention period)
- Fasting blood glucose(Before and after the 12 week intervention/intervention period)
- Continuous blood glucose(Before and after the 12 week intervention/intervention period)
- Physical function - the short physical performance battery(Before and after the 12 week intervention/intervention period)
- Body mass index (BMI)(Before and after the 12 week intervention/intervention period)
- Objectively measured sleep - wake after sleep onset(Before and after the 12 week intervention/intervention period)
- Objectively measured sleep - sleep onset latency(Before and after the 12 week intervention/intervention period)
- Objectively measured sleep - total sleep time(Before and after the 12 week intervention/intervention period)
- Objectively measured sleep - sleep duration variability(Before and after the 12 week intervention/intervention period)
- Objectively measured sleep - sleep midpoint variability(Before and after the 12 week intervention/intervention period)
- Objectively measured sedentary behaviour(Before and after the 12 week intervention/intervention period)
- Objectively measured physical activity(Before and after the 12 week intervention/intervention period)
- Subjectively measured sleep - insomnia(Before and after the 12 week intervention/intervention period)
- Subjectively measured sleep quality -(Before and after the 12 week intervention/intervention period)
- Subjectively measured sleepiness(Before and after the 12 week intervention/intervention period)
- Insulin(Before and after the 12 week intervention/intervention period)
- Physical function - the sit to stand-60(Before and after the 12 week intervention/intervention period)
- Triglycerides(Before and after the 12 week intervention/intervention period)
- Cholesterol(Before and after the 12 week intervention/intervention period)
- Body composition - via bioimpedance(Before and after the 12 week intervention/intervention period)
- Depression - The Patient Health Questionnaire-9 (PHQ9)(Before and after the 12 week intervention/intervention period)
- Food intake - food diaries(Before and after the 12 week intervention/intervention period)
- Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)(Before and after the 12 week intervention/intervention period)
- Cognitive function - verbal fluency test(Before and after the 12 week intervention/intervention period)
- Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)(Before and after the 12 week intervention/intervention period)
- Weight(Before and after the 12 week intervention/intervention period)
- Height(Before and after the 12 week intervention/intervention period)
- Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)(Before and after the 12 week intervention/intervention period)