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Can mindfulness fix sleep and cut heart risk in black women?

NCT ID NCT06348082

Symptom relief Sponsor: Yale University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests a 6-week mindfulness-based program designed to improve sleep and reduce stress in Black women with insomnia. Researchers will enroll 340 women and track changes in sleep quality, stress levels, and how acceptable and feasible the program is. The goal is to see if this approach can help reduce the higher rates of heart disease linked to poor sleep in this group.

What this could mean

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

Active substance
mindfulness-based therapy for insomnia (MBTI)
What this could lead to
If successful, this program could offer an effective, non-drug way to improve sleep and reduce stress in Black women, potentially lowering their risk for heart disease.
What could go wrong
This is a behavioral intervention study, not a drug trial. Results depend on participants sticking with the program, and benefits may vary. It is still early, and larger studies would be needed to confirm any long-term health impact.

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

29 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Sep 2026

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 to 70 years

Sex

Female participants only

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: * self-identified Black women * English speaking * meet ICSD3 diagnostic criteria for insomnia disorders, defined as difficulty initiating or maintaining sleep that occurs despite adequate opportunity to sleep with at least one associated daytime impairment symptom (ISI \> 7) * additional quantitative insomnia criteria based on research recommendations and the new ICSD3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31 min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months. Exclusion Criteria: * Psychosis or unstable/significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily) * significant current practice of any form of meditation (\>15min per day) * obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, use of medication that influence circadian rhythm, e.g., Parkinson's disease) * active or terminal cancer.

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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.

Cardiometabolic health Insomnia Sleep health

Contacts and locations

Locations

  • Yale School of Nursing

    New Haven, Connecticut, 06477, United States

  • Yale School of Nursing Biobehavioral Lab

    West Haven, Connecticut, 06516, United States

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