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NCT Number: NCT06471634

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Insomnia Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Sedentary Behavior Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Research Centre University Hospitals Leicester

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location status: Recruiting

Location contact

Alix HA Covenant, MSc

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBTI

Behavioral

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.

Control - usual care

Other

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.

Sedentary behaviour reduction

Behavioral

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 outcomes

  1. 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

  1. Objectively measured sleep - sleep onset latency

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure sleep onset latency in minutes.

  2. Objectively measured sleep - wake after sleep onset

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure wake after sleep onset in minutes.

  3. Objectively measured sleep - total sleep time

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure total sleep time in minutes.

  4. Objectively measured sleep - sleep duration variability

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure sleep duration variability in minutes.

  5. Objectively measured sleep - sleep midpoint variability

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure sleep midpoint variability in minutes.

  6. Objectively measured sedentary behaviour

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure total time spent in sedentary time in minutes.

  7. Objectively measured physical activity

    Time frame: Before and after the 12 week intervention/intervention period

    Accelerometer data will be used to measure total time spent in physical activity in minutes.

  8. Subjectively measured sleep - insomnia

    Time frame: Before and after the 12 week intervention/intervention period

    The Insomnia Severity index, will be used to measure the level of insomnia - it is a questionnaire and has a range of 0-28 with higher scores indicating more insomnia.

  9. Subjectively measured sleep quality -

    Time frame: Before and after the 12 week intervention/intervention period

    The Pittsburgh Sleep Quality Index will be used to measure subjective sleep quality, this is a questionnaire and has a range of 0-21 with higher scores indicating worse sleep quality.

  10. Subjectively measured sleepiness

    Time frame: Before and after the 12 week intervention/intervention period

    Epworth Sleepiness Scale is a questionnaire and has a range of 0-24 with higher scores indicating more sleepiness.

  11. Measurement of fatigue

    Time frame: Before and after the 12 week intervention/intervention period

    The Functional assessment of chronic illness therapy (FACIT) scale will be used to subjectively measure fatigue, the range is 0-52 with higher scores indicating less fatigue.

  12. Blood pressure

    Time frame: Before and after the 12 week intervention/intervention period

    Blood pressure (both diastolic and systolic) will be measured using an automatic electronic device and the units used will be millimetres of mercury.

  13. Fasting blood glucose

    Time frame: Before and after the 12 week intervention/intervention period

    Fasting measured via a venous sample and in millimoles per litre (Mmol/L)

  14. Continuous blood glucose

    Time frame: Before and after the 12 week intervention/intervention period

    Continuous blood glucose measured via a continuous glucose monitor and in Mmol/L (Mmol/L)

  15. Insulin

    Time frame: Before and after the 12 week intervention/intervention period

    Insulin will be measured via a venous sample and in micro units per millilitre.

  16. Triglycerides

    Time frame: Before and after the 12 week intervention/intervention period

    Triglycerides will be measured via a venous sample and in Mmol/L.

  17. Cholesterol

    Time frame: Before and after the 12 week intervention/intervention period

    Cholesterol, including Low density lipoprotein and high density lipoprotein and total cholesterol, will be measured via a venous sample and in Mmol/L

  18. Physical function - the short physical performance battery

    Time frame: Before and after the 12 week intervention/intervention period

    The short physical performance battery consists of 3 physical tests, with a total score range of 0-12 with higher scores indicating better physical function.

  19. Physical function - the sit to stand-60

    Time frame: Before and after the 12 week intervention/intervention period

    The sit to stand-60 is the number of times the participant can rise from sit to stand in one minute using a designated chair with no arms and without the use of the participants arms, and is reported as a number.

  20. Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)

    Time frame: Before and after the 12 week intervention/intervention period

    WHODAS is a questionnaire used to assess both physical and cognitive function. Each question is scored 0-4, scores are then averaged for all the questions so the range is 0-4 and the higher the score the more difficulty the participant is experiencing in functioning.

  21. Cognitive function - verbal fluency test

    Time frame: Before and after the 12 week intervention/intervention period

    Cognitive function will be measured using the verbal fluency test, which is conducted over two 60s periods and is scored by the number of correct answers.

  22. Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)

    Time frame: Before and after the 12 week intervention/intervention period

    EQ-5D-5L, the five questions are scored 1-5 and each represents a different aspect, it is presented as a five digit number representing each domain. The higher the numbers, the worse quality of life.

  23. Weight

    Time frame: Before and after the 12 week intervention/intervention period

    Weight in kilograms will be measured.

  24. Height

    Time frame: Before and after the 12 week intervention/intervention period

    Height in metres will be measured.

  25. Body mass index (BMI)

    Time frame: Before and after the 12 week intervention/intervention period

    BMI will be calculated using weight and height to produce BMI in kg/m^2

  26. Body composition - via bioimpedance

    Time frame: Before and after the 12 week intervention/intervention period

    Bioimpedance scales will be used to measure body composition including percentage fat, muscle mass and water

  27. Depression - The Patient Health Questionnaire-9 (PHQ9)

    Time frame: Before and after the 12 week intervention/intervention period

    PHQ9 will be used to measure depressive symptoms. The PHQ9 has a range of 0-27 with higher scores indicating more depressive symptoms/depression.

  28. Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)

    Time frame: Before and after the 12 week intervention/intervention period

    GAD7 will be used to measure anxiety symptoms. It has a range of 0-21, with higher scores indicating more anxiety.

  29. Food intake - food diaries

    Time frame: Before and after the 12 week intervention/intervention period

    3 Day food diaries will be used to measure food intake.

Study contacts

Contact information is provided by the study sponsor or research team.

Alix HA Covenant, MSc

CONTACT

[email protected]

01162588572

Joe Henson, PhD

CONTACT

[email protected]

1162588572

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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