NCT07337915 · The University of Texas Medical Branch, Galveston
Improving Sleep In Midlife Women
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
HealthyHabits1
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).
BEHAVIORAL
HealthyHabits2
Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.
OTHER
Snack 2
Participants in this group will consume 2 servings of pistachios daily for 30 days
OTHER
Snack 1
Participants in the group will consume 2 servings of potato chips daily for 30 days.
Primary outcome measures
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, End of intervention period (up to Week 4)
PSQI is a questionnaire that assesses sleep quality, including both subjective experiences and objective parameters. There are 19 questions that are grouped into 7 components to create a global score. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
Where
- Galveston, Texas
Collaborators
American Pistachio Growers
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations