Sleep study targets racism stress impact on insomnia treatment
NCT ID NCT07445529
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This study looks at whether racism-related stress affects how well a digital cognitive behavioral therapy program (Sleepio) works for insomnia in Black adults. One hundred participants will use the app for 6-10 weeks while researchers track their sleep and stress levels. The goal is to see if those with short sleep benefit less and whether stress plays a role.
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) delivered via a digital program called Sleepio
- What this could lead to
- If successful, this could show that digital CBT for insomnia works well for Black adults, even when they face racism-related stress.
- What could go wrong
- This is a small, early-stage study with no control group, so results may not apply to everyone. The digital program may not work as well for those with very short sleep.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
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 to 65 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: * Non-Hispanic Black adults * aged 18-65 years with * Clinically Significant \[Insomnia Severity Index (ISI) score \> 1048\] insomnia symptoms and * clinically significant depressive symptoms \[PHQ-9 total score \>9\]. Exclusion Criteria: * Current alcohol or substance use issues, * Current active suicidal ideation * Current shift-worker or frequent time zone travel * Severe psychiatric morbidity within 6 months or lifetime history of bipolar disorder, mania, psychotic disorder * delirium or dementia, which would interfere with participation * major medical comorbidities * history of seizures * sleep apnea * Lastly, people using antidepressant or psychiatric medications may be included if on a stable dosage for the last 1-month prior to the study and intend to remain on the medication during the study.
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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 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.
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