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Recruiting NCT07337915

Improving Sleep In Midlife Women

No phase Interventional Poor Sleep Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HealthyHabits1, HealthyHabits2, Snack 2, Snack 1.
Who it may be relevant to
Registry conditions: Poor Sleep Quality. Basic parameters: 45 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improving Sleep in Midlife Women

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.

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)]
Secondary outcome measures (12)
  • Change in Seated blood pressure [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in Body Weight [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance [Time frame: Baseline, End of intervention (up to Week 4)]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in 24-h Urinary Melatonin [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in plasma IL-6 [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in Psychomotor Vigilance Testing (PVT) [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in sleep health measured by RU-SATED [Time frame: Baseline, End of intervention period (up to Week 4)]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue [Time frame: Baseline, End of Intervention (Up to Week 4)]
  • Change in visceral fat [Time frame: Baseline, End of intervention (up to Week 4)]
  • Change in sleep latency assessed by actigraphy [Time frame: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)]
  • Change in sleep latency assessed by sleep diary [Time frame: Baseline, Post-intervention (Up to Week 5)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Texas Medical Branch — Galveston

Identifiers

NCT: NCT07337915 · 25-0194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗