A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

Official title

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

Overview

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.

Interventions

• Behavioral CBTi
  A 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.
• Other Control - usual care
  Participants 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.
• Behavioral Sedentary behaviour reduction
  Participants 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.

Primary outcome measures

• Sleep Efficiency (SE) measured using accelerometer data. [Time frame: Before and after the 12 week intervention/intervention period]

Secondary outcome measures (12)

• Objectively measured sleep - sleep onset latency [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured sleep - wake after sleep onset [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured sleep - total sleep time [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured sleep - sleep duration variability [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured sleep - sleep midpoint variability [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured sedentary behaviour [Time frame: Before and after the 12 week intervention/intervention period]
• Objectively measured physical activity [Time frame: Before and after the 12 week intervention/intervention period]
• Subjectively measured sleep - insomnia [Time frame: Before and after the 12 week intervention/intervention period]
• Subjectively measured sleep quality - [Time frame: Before and after the 12 week intervention/intervention period]
• Subjectively measured sleepiness [Time frame: Before and after the 12 week intervention/intervention period]
• Measurement of fatigue [Time frame: Before and after the 12 week intervention/intervention period]
• Blood pressure [Time frame: Before and after the 12 week intervention/intervention period]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Diabetes Research Centre University Hospitals Leicester — Leicester

Identifiers

NCT: NCT06471634 · 0955 · 334347

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗