Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a sleep therapy and melatonin combo help older adults beat chronic insomnia?

NCT ID NCT07695246

Symptom relief Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests whether adding melatonin to cognitive behavioural therapy for insomnia (CBT-I) improves sleep in adults aged 60 and older with chronic insomnia. Participants are randomly assigned to receive CBT-I plus melatonin, CBT-I plus a placebo, or sleep education plus a placebo, all over four weekly group sessions. The goal is to see if the combination reduces insomnia symptoms more than CBT-I alone or education alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin 3 mg immediate-release
What this could lead to
If successful, this could point toward a combined behavioural and medication approach to improve sleep in older adults without long-term drug dependence.
What could go wrong
This is a relatively small, early-stage trial, and the effects of melatonin added to CBT-I may be modest. Results may not apply to all older adults or those with other health conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 183 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Chinese aged ≥ 60. 2. Provision of written informed consent. 3. 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). 4. Having a score of \> 14 on the ISI, indicating clinical insomnia. Exclusion Criteria: 1. 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. 2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain). 3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy). 4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder. 5. Having mild to significant cognitive impairment, defined by having a score of \< 22 on MOCA. 6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon). 7. Receiving concurrent psychological treatment for insomnia. 8. 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). 9. Being a night shift worker.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aging are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

insomnia sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aging Insomnia Sleep disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.