Can your sleep length predict the best insomnia cure?
NCT ID NCT06281756
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at 600 adults with chronic insomnia to see if those who sleep less than 6 hours respond differently to treatment than those who sleep longer. Participants first receive 8 weeks of cognitive behavioral therapy (CBT-I). If that doesn't help, they are randomly assigned to take either the medication trazodone or a placebo for another 8 weeks. The goal is to improve sleep and lower blood pressure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trazodone
- What this could lead to
- If successful, this could help doctors choose the best insomnia treatment for each patient, potentially reducing high blood pressure risks.
- What could go wrong
- This is an early-phase study, so results are uncertain. The treatments may not work differently for the two insomnia types, and benefits may not be large.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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May 2028
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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18 years and older
- 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 18 or older * Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site. * Meets criteria for chronic insomnia * Body Mass Index (BMI) 18.5 kg/m2 and higher Exclusion Criteria: * Age \< 18 * Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site. * Unwilling to share email address/cell phone number to accept survey links. * Life time diagnosis of psychotic or bipolar disorder * History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss. * Started new or changed treatment for sleep apnea in the past three months * Does not meet criteria for chronic insomnia * Meets criteria for narcolepsy or hypersomnia disorder * Meets criteria for circadian rhythm disorder (including night shift work) * Unstable medical conditions that would make participation unsafe or unfeasible * Falls resulting in hospitalization, significant injury or fracture within past 12 months * 2 hospitalizations or emergency room visits within past 12 months for chronic conditions * Active chemotherapy or radiation therapy for cancer * Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure * Does not agree to refrain from other treatments for insomnia beyond what is offered in this study * BMI less than 18.5 * Substance abuse or dependence in the past 12 months * Current use of prescription or over the counter medications taken for sleep greater than 2 times per week * Current use of systemic corticosteroids or opiate medications * Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study * Current use of medications contraindicated with trazodone * Sleep apnea or periodic leg movement disorder as determined by sleep study * Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg * EKG corrected QT interval greater than or equal to 500 ms
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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
4 sites in 2 countries. 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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National Jewish Health
RECRUITINGDenver, Colorado, 80206-2761, United States
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Penn State University
RECRUITINGHershey, Pennsylvania, 17033, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15213-3203, United States
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Université Laval
RECRUITINGQuébec, Quebec, G1V 0A6, Canada
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