Improving sleep for women in midlife.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Overnight Temperature Regulation to Test Gut Health, Inflammation, and Circadian Rhythms

  This study tests whether two weeks of using the Eight Sleep Pod at night can improve gut bacteria balance, lower inflammation, and strengthen daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with poor sleep.

  Recruiting Eight Sleep Inc. · Newton Center, Massachusetts · NCT07848594

• Sleep and arterial function in hypertensive patients with poor sleep quality

  This trial tests whether using cognitive-behavioural therapy for insomnia can improve artery health and well-being in adults with high blood pressure and poor sleep.

  Recruiting Unidade Local de Saúde do Alto Ave, EPE · Guimarães, Braga District · NCT07789535

• Magnesium and melatonin nightly supplement for nighttime leg cramps and poor sleep

  A nightly magnesium and melatonin supplement is being tested to see if it improves sleep quality in adults with nighttime leg cramps.

  Recruiting at 7 sites StudySetGo · Birmingham, Alabama and 6 other locations · NCT07651514

• Pistachio snacking to improve metabolic flexibility in adults with overweight

  We will try eating pistachios for a few days to see if it helps adults with overweight or obesity use energy better at rest, during exercise, and after exercise.

  Recruiting University of South Carolina · Columbia, South Carolina · NCT07340125

• Effects of eating walnuts on sleep quality

  This study is testing if eating walnuts can help middle-aged and older adults who have trouble sleeping get better rest compared to eating sugary foods.

  Recruiting Columbia University · New York, New York · NCT06430086

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.