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Improving Sleep In Midlife Women

Improving Sleep In Midlife Women

Recruiting
45-65 years
Female
Phase N/A

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Overview

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

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

Study details
    Poor Sleep Quality

NCT07337915

The University of Texas Medical Branch, Galveston

13 May 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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