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Completed
NCT04831385
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Conditions: Diabetes Mellitus, Type 2, Insomnia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 214
Sponsor: Chinese University of Hong Kong
Location: 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
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 function in Hong Kong Chinese older T2D comorbid with insomnia.
Eligibility Criteria
Inclusion Criteria:
1. Aged ≥60 years;
2. T2D with suboptimal glycemic control defined as HbA1c 7.1-10%;
3. Chinese ethnicity;
4. Comorbid with insomnia having ISI score \>10;
5. Able and willing to give informed written consent
Exclusion criteria:
1. Cognitive impairment (HK-MoCA score of ≤22);
2. 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;
3. 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;
4. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep;
5. Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function;
6. Shift workers;
7. Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia;
8. Any condition, as judged by the investigators, as ineligible to participate in this study.
Source: ClinicalTrials.gov (NCT04831385). StuddyBuddy aggregates publicly available trial information.