NCT07337915NARecruiting
Improving Sleep In Midlife Women
The University of Texas Medical Branch, Galveston
Start Date
2/16/2026
Completion Date
8/31/2027
Summary
This study purpose of this study to see how consuming pistachios and completing a health intervention session a study therapist may improve sleep health in midlife women with poor sleep. Participants in this study will be asked to consume a study snack for about one month, complete a health education session with a study therapist and record information about their sleep. At baseline and after the intervention we will collect information about sleep, alertness, body composition, and blood lipids.
Eligibility Criteria
Age Range: 45 years to 65 years
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
Interventions
BEHAVIORAL
HealthyHabits1
BEHAVIORAL
HealthyHabits2
OTHER
Snack 2
OTHER
Snack 1
Conditions
Poor Sleep Quality
Locations
University of Texas Medical Branch
Galveston, Texas 77555
United States