Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06471634
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06471634
Study Brief:
Protocol Section:
NCT06471634