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Active Not Recruiting
NCT06348082
Project Women's Insomnia Sleep Health Equity Study (WISHES)
Conditions: Insomnia, Sleep Health, Cardiometabolic Health
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 29
Sponsor: Yale University
Location: Yale School of Nursing New Haven Connecticut
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06348082). StuddyBuddy aggregates publicly available trial information.