NCT04831385Completed
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 214 (actual)
- First submitted
- 1 Apr 2021
- Start date
- 1 May 2022
- Primary completion date
- 22 Jun 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Type 2 diabetes
- NCT number
- NCT04831385
What you commit to
- Study type: Interventional
- Participants enrolled: 214
- From 1 May 2022 to the primary completion date, 22 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep;
Other illness
- 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;
- Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function;
- Any condition, as judged by the investigators, as ineligible to participate in this study.
Lab values
- Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia;
Other
- Shift workers;
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.