NOT_YET_RECRUITING
Project Women's Insomnia Sleep Health Equity Study (WISHES)
The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.
Conditions:
🦠 Insomnia 🦠 Sleep Health 🦠 Cardiometabolic Health
🗓️ Study Start (Actual) September 2025
🗓️ Primary Completion (Estimated) July 2028
✅ Study Completion (Estimated) July 2028
👥 Enrollment (Estimated) 340
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 West Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 February 2024
  • First Submitted that Met QC Criteria 28 March 2024
  • First Posted 4 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 April 2024
  • Last Update Posted 5 April 2024
  • Last Verified April 2024