Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT04831385

The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia

Led by Chinese University of Hong Kong · Updated on 2025-07-11

214

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 60 years or older
  • Diagnosed with type 2 diabetes with HbA1c between 7.1% and 10%
  • Of Chinese ethnicity
  • Have insomnia with an Insomnia Severity Index (ISI) score greater than 10
  • Able and willing to give informed written consent
Not Eligible

You will not qualify if you...

  • Cognitive impairment with HK-MoCA score of 22 or less
  • Depression with GDS-15 score greater than 8 or other psychiatric disorders such as generalized anxiety disorder, restless leg syndrome, or schizophrenia
  • History of benign prostatic hypertrophy or elevated PSA, or other chronic medical conditions affecting sleep such as chronic pain
  • Current use of hypnotic drugs, psychotic medications, or any drugs known to affect sleep
  • History of cerebrovascular accidents, vascular dementia, or other conditions affecting cognitive function
  • Shift workers
  • Conditions affecting the validity of HbA1c measurement such as haemoglobinopathies, renal failure, or need for regular blood transfusion
  • Any condition deemed by investigators as ineligible for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

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

Actively Recruiting

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Research Team

A

Alice Kong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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