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Adding diet and exercise advice to insomnia therapy shows promise in small study

NCT ID NCT06550388

Symptom relief Sponsor: Mayo Clinic 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding brief advice on the Mediterranean diet and physical activity to standard cognitive behavioral therapy for insomnia (CBT-I) could improve sleep quality. Five adults with chronic insomnia participated. Researchers measured sleep quality and insomnia severity before and after the lifestyle intervention. The goal was to see if these simple additions could make standard therapy work even better.

What this could mean

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

Active substance
Mediterranean diet education and increased physical activity
What this could lead to
If it works, this could point toward simple lifestyle changes that boost the effectiveness of standard insomnia therapy.
What could go wrong
This is a tiny pilot study with only 5 participants, so results may not apply to everyone. The lifestyle changes are added to existing therapy, making it hard to know what caused any improvement.

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

5 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

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 to 70 years

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: * Diagnosis of Chronic Insomnia * 18-70 years of age Exclusion Criteria: * Known untreated sleep disorder * Cardiovascular diagnosis that would not allow safe increase of physical activity * Diabetes * Pregnancy or lactation * Current use of a vegan diet or Mediterranean diet * BMI ≤ 22 * Score higher than 15 on PHQ-8 * Diagnosed with a severe neurological or sensory impairment that would significant impact participation * Currently performing shift work/diagnosis of a circadian rhythm disorder

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Insomnia chronic

Contacts and locations

Locations

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

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