Improving sleep for women in midlife.
Improving Sleep in Midlife Women
This project tests whether eating pistachios daily and completing a health-education session can help women aged 45–65 with poor sleep sleep better and improve alertness and some health measures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT07337915 on ClinicalTrials.gov |
What this trial studies
This single-site interventional study enrolls women aged 45–65 who are in late peri-menopause or early post-menopause and report poor sleep (PSQI > 5). Participants will consume a provided pistachio snack daily for about one month, complete a health education session with a study therapist via teleconferencing, and record sleep information during the intervention. Investigators will collect baseline and post-intervention measures including sleep outcomes, daytime alertness, body composition, and blood lipids. The study is run at the University of Texas Medical Branch in Galveston with some sessions conducted remotely.
Who should consider this trial
Good fit: Women aged 45–65 in late peri-menopause or early post-menopause with poor sleep (PSQI > 5), who can use teleconferencing and are willing to consume the study snack, are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, currently using medications that affect sleep, outside the specified age or menopausal stage, or unable/unwilling to follow the snack or telehealth requirements are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could offer a low-risk, easy-to-adopt snack plus education approach to improve sleep and potentially metabolic health in midlife women.
How similar studies have performed: Behavioral sleep programs and some dietary interventions have produced modest sleep improvements, but using pistachios specifically as a sleep-targeted snack is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All races and ethnic backgrounds * Between the ages of 45-65 years old * Women who meet STRAW staging criteria for late peri-menopause (STRAW score of -1) defined as interval of amenorrhea of 60 days OR meet STRAW staging criteria for early post-menopause (STRAW score of +1a, +1b or +1c) defined as \>12 months since last menstrual period * History of poor sleep quality (Pittsburgh Sleep Quality Index score \> 5) * Able and willing to provide informed consent * Access to an electronic device with teleconferencing capabilities (Teams, etc) * Willing to consume study intervention * Fluent (able to read and write) in English Exclusion Criteria: * Pregnancy or lactation * Recent (within the last 3 months) or current use of any prescription or over the counter medications that may impact sleep quality: 1. including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy) 2. recent (within the last 3 months) change in antidepressant medication useage or dosage * Untreated comorbid sleep disorders that are no known to be responsive to the behavioral interventions: These sleep disorders include but are not limited to narcolepsy, circadian rhythm disorder/shift work, restless leg syndrome, periodic leg movement disorder, obstructive sleep apnea. * Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years) that would, in the opinion of the investigator, affect sleep and/or make it difficult for the participant to the investigators instructions. * Recent (within past 3 years) treated cancer other than basal cell carcinoma * Current adherence to a weight-loss or weight-gain diet or use of GLP-1 RA medications * Active or recent (within the past 12 months) alcohol or substance use disorder * Allergy to study intervention (tree nuts) * Any other condition or event considered exclusionary by study PI
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Emily Lantz, PhD — University of Texas
- Study coordinator: Paula Skinkis, M.Ed
- Email: pskinkis@utmb.edu
- Phone: 409-772-1907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.