Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia

Starting soon · Not applicable · Has a placebo group

Conditions studied: Insomnia, Aging, Sleep Disorders

In brief

This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.

Key facts

Study ID

NCT07695246

Run by

The University of Hong Kong

People needed

183

Starts

2026-08-01

Expected to finish

2029-08-01

Last updated by the study team

2026-07-10

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chinese aged ≥ 60.
• Provision of written informed consent.
• Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).
• Having a score of > 14 on the ISI, indicating clinical insomnia.

You may not qualify if…

• Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.
• Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).
• Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).
• Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder and circadian sleep-wake phase disorder.
• Having mild to significant cognitive impairment, defined by having a score of < 22 on MOCA.
• Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).
• Receiving concurrent psychological treatment for insomnia.
• Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).
• Being a night shift worker.

Where it is running

• Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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