RecruitingNot ApplicableNCT07337915

Improving Sleep In Midlife Women

Improving Sleep in Midlife Women


Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

72 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 45 YearsMax Age: 65 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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:
  • including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
  • 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

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Interventions

BEHAVIORALHealthyHabits1

Participants in this group will be coached in a one hour session with a study therapist how to improve healthy habits (e.g.,diet/nutrition, activity, sleep).

BEHAVIORALHealthyHabits2

Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.

OTHERSnack 2

Participants in this group will consume 2 servings of pistachios daily for 30 days

OTHERSnack 1

Participants in the group will consume 2 servings of potato chips daily for 30 days.


Locations(1)

University of Texas Medical Branch

Galveston, Texas, United States

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NCT07337915


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