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Fixing sleep may unlock better weight loss: a trial tests the combo

NCT ID NCT07770516

Disease control Sponsor: Chinese 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study tests whether adding cognitive behavioral therapy for insomnia (CBTI) to a flexible time-restricted eating plan helps adults with overweight or obesity and chronic insomnia lose more weight. Participants will either follow the eating plan alone or combine it with CBTI, a proven treatment for insomnia. The goal is to see if improving sleep can make weight loss efforts more effective.

What this could mean

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

Active substance
Cognitive behavioral therapy for insomnia (CBTI) combined with flexible time-restricted eating (FTRE)
What this could lead to
If successful, this could point toward a combined lifestyle program that improves both sleep and weight loss in people with chronic insomnia and overweight.
What could go wrong
This is a small early-stage trial, so results may not apply broadly. The added benefit of CBTI on weight loss is uncertain, and adherence to the eating schedule may vary.

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 50 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

18 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. Ethnic Chinese; 2. Age 18 years or older; 3. Fulfill the criteria of chronic insomnia defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) , which are: i. manifestation of predominant, subpar sleep quantity or quality; ii. exhibition of any sleep difficulties ranging from sleep initiation, sleep maintenance to early awakening with the inability to restore sleep. iii. concomitant presentation of significant distress or impairment, including fatigue or low energy, cognitive impairment, mood disturbance, behavioral problems, impaired occupational or academic functioning, impaired interpersonal or social functioning and negative impact on caregiver or family functioning; iv. sleep difficulty occurs at least three nights per week; v. sleep difficulty has been persistent for at least three months; and vi. sleep difficulty is not affected regardless of adequate opportunity given for sleep. 4. With Overweight or obesity: BMI ≥ 23 kg/m2 5. Weight stable for the past 3 months 6. Habitual eating window ≥ 10 hours Exclusion Criteria: 1. Known cardiovascular disease; 2. Type 1 or 2 diabetes mellitus; 3. Current use of GLP-1 receptor agonists or other prescription weight-loss medications within the past 3 months; 4. Currently on a special or prescribed diet for other reasons; 5. Currently receiving any psychological treatment for insomnia; 6. Previously received CBTI; 7. Night shift workers; 8. Breastfeeding, pregnant or trying to become pregnant; 9. Smokers.

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Conditions

The condition(s) this trial relates to.

insomnia Intermittent Fasting Obesity obesity disorder Overweight

As listed by the trial registrant

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

Chronic insomnia Overweight , obesity

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

  • Kwok Sports Building, The Chinese University of Hong Kong

    Hong Kong, 00000, Hong Kong

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