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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04831385). StuddyBuddy aggregates publicly available trial information.