No pills, just therapy: new trial targets insomnia in active adults
NCT ID NCT07607444
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study tests whether cognitive behavioral therapy for insomnia (CBT-I) can reduce insomnia severity in physically active adults aged 30-59. Fifty participants will either receive 6 weeks of CBT-I or no treatment. The main goal is to see if CBT-I improves sleep quality and reduces daytime complaints.
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 (CBT-I)
- What this could lead to
- If it works, this could offer a drug-free way to improve sleep for active people with insomnia.
- What could go wrong
- This is a small, early-stage trial with only 50 participants and no blinding, so results may not apply broadly. The therapy requires commitment and may not work for everyone.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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30 to 59 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age range between 30-59 years; * Practice regular physical exercise for over 150 minutes per week; * Complaints of insomnia (difficulty initiating and/or maintaining sleep and/or early awakening) more than three times a week, for at least three months, associated with complaints of daytime impairments (occupational, academic or social) related to insomnia; * Insomnia severity index greater than fifteen (\>15). Exclusion criteria: * Shift workers; * Evidence that insomnia is associated with restless legs syndrome; * Evidence that insomnia is associated with medication side effects; * Evidence that insomnia is associated with signs or symptoms of mental disorders; * Abusive use of alcohol or illicit psychoactive substances.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tamara R. L. Zanuzzi
RECRUITINGJatai, Goiás, 75801-615, Brazil
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