The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Recruiting now · Not applicable
Conditions studied: Diabetes Mellitus, Type 2, Insomnia
In brief
This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia.
Key facts
- Study ID
- NCT04831385
- Run by
- Chinese University of Hong Kong
- People needed
- 214
- Starts
- 2022-05-01
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-07-11
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged ≥60 years;
- T2D with suboptimal glycemic control defined as HbA1c 7.1-10%;
- Chinese ethnicity;
- Comorbid with insomnia having ISI score >10;
- Able and willing to give informed written consent
You may not qualify if…
- Cognitive impairment (HK-MoCA score of ≤22);
- Depression (GDS-15 score >8) and other psychiatric disorders e.g. generalized anxiety disorder, restless leg syndrome, schizophrenia to be elucidated by history from research nurse and questionnaires;
- Benign prostatic hypertrophy by history and/or elevated PSA and any other chronic medical condition that is likely to affect sleep e.g. chronic pain;
- Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep;
- Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function;
- Shift workers;
- Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia;
- Any condition, as judged by the investigators, as ineligible to participate in this study.
Where it is running
- Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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