Status:
RECRUITING
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetes Mellitus, Type 2
Insomnia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 f...
Detailed Description
Insomnia is the most common sleep disorders affecting 10% to 30% of the population, imposing a huge burden on healthcare systems. While the amount of deep sleep (slow wave and rapid eye movement) decl...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04831385
Start Date
May 1 2022
End Date
August 31 2026
Last Update
July 11 2025
Active Locations (1)
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1
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