Improving Sleep In Midlife Women

Improving Sleep in Midlife Women

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.

Study Overview

• Status: Recruiting
• Conditions: Poor Sleep Quality
• Intervention / Treatment: Behavioral: HealthyHabits1; Other: Snack 1; Behavioral: HealthyHabits2; Other: Snack 2

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Lantz, PhD; Email: ejlantz@utmb.edu
• Study Contact Backup: Name: Paula Skinkis, M.Ed; Phone Number: 409-772-1907; Email: pskinkis@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Emily Lantz, PhD; Phone Number: 409-772-0643; Email: ejlantz@utmb.edu
      • Contact: Paula Skinkis, M.Ed; Phone Number: 409-772-1907; Email: pskinkis@utmb.edu
      • Principal Investigator: Emily J Lantz, PhD
      • Sub-Investigator: Sara Nowakoski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Snack 1 + HeathyHabits1; Participants in this arm will consume 2 servings of potato chips per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).	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).; Other: Snack 1; Participants in the group will consume 2 servings of potato chips daily for 30 days.
Other: Snack 2 + HealthyHabits2; Participants in this arm will consume 2 servings of pistachios for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve sleep habits.	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 2 + HealthyHabits1; Participants in this arm will consume 2 servings of pistachios per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).	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).; Other: Snack 2; Participants in this group will consume 2 servings of pistachios daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)	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.	Baseline, End of intervention period (up to Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Seated blood pressure	In-office diastolic and systolic blood pressure will be measured using standard equipment. Blood pressure will be measures in mmHg.	Baseline, End of intervention period (up to Week 4)
Change in Body Weight	Body Weight will be measured using a standardized scale and reported in kg.	Baseline, End of intervention period (up to Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance	PROMIS Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. It is an 4-item questionnaire that has participants answer questions about perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep ranked from "not at all" to "always". A higher score indicates more severe sleep issues.	Baseline, End of intervention (up to Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment	The PROMIS Sleep Related Impairment questionnaire measures perception of sleepiness during usual awake hours. It is an 4-item questionnaire that has participants answer questions about how sleepiness interfered with their awake-time activities ranked from "not at all" to "always". A higher score indicates greater inference with sleepiness related interference.	Baseline, End of intervention period (up to Week 4)
Change in 24-h Urinary Melatonin	Participants will collect urine at home for 24 h to be analyzed for urinary output of 6-sulfatoxymelatonin (aMT6s)melatonin, a metabolite of melatonin. Melatonin is a hormone naturally produced by your body as a signal that it is time for sleep.	Baseline, End of intervention period (up to Week 4)
Change in plasma IL-6	Plasma IL-6 will be measured using usual laboratory methodology. IL-6 is an inflammatory marker produced by the body. A decrease in IL-6 is considered an improvement.	Baseline, End of intervention period (up to Week 4)
Change in Psychomotor Vigilance Testing (PVT)	Alertness and attention will be measured using standard 5 minute psychomotor vigilance testing. PVT simply involves responding to a light by pressing a button on a small handheld device.	Baseline, End of intervention period (up to Week 4)
Change in sleep health measured by RU-SATED	RU-SATED stands for Regularity, Satisfaction, Alertness, Timing, Efficiency, Duration and is a 6-question validated multidimensional sleep health instrument measuring dimensions of sleep health. Participants are asked to rank components of their sleep health over the previous month. Items are each rated on three-point Likert scale from 0 (Rarely / Never) to 2 (Usually / Always), resulting in a total score from 0 to 12. A higher score indicating better sleep health.	Baseline, End of intervention period (up to Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue	The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.	Baseline, End of Intervention (Up to Week 4)
Change in visceral fat	Visceral fat will be measured using dual x-ray absorptiometry. A greater change in visceral fat is considered good.	Baseline, End of intervention (up to Week 4)
Change in sleep latency assessed by actigraphy	Sleep latency is defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency will be assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. A mean value will be calculated with 7 days of wear. A negative change from Baseline indicates improvement.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in sleep latency assessed by sleep diary	Sleep latency is defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency will be recorded by the participant in a diary. A mean value will be calculated with 7 days. A negative change from Baseline indicates improvement.	Baseline, Post-intervention (Up to Week 5)
Change in total sleep time assessed by sleep diary	Total nocturnal sleep time by diary will be calculated as total time in bed (awaking hour - bedtime hour) from which sleep latency was subtracted. Mean value from the past 7 days at each timepoint will be evaluated. A positive change from Baseline indicates improvement.	Baseline, End of intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in total sleep time assessed by actigraphy	Total nocturnal sleep time will be assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Total nocturnal sleep time by actigraphy was total time in bed from which sleep latency, nocturnal wake time, and the time from waking up to leaving the bed were subtracted. Mean value from the past 7 days at each timepoint will be evaluated. A positive change from Baseline indicates improvement.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in nocturnal awakenings assessed by actigraphy	The number of nocturnal awakenings will be assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each time point will be evaluated. A positive change from Baseline indicates a worsening.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in nocturnal awakenings assessed by sleep diary	The number of nocturnal awakenings will be recorded by the participant in a diary. Mean value from the past 7 days at each timepoint will be evaluated. A negative change from Baseline indicates improvement.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in sleep efficiency assessed by actigraphy	Sleep efficiency is defined is the percentile of total sleep time (TST) to time in bed (TIB), calculated as [(Total sleep time/total time in bed) * 100]. Sleep efficiency will be assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint will be evaluated. A positive change from Baseline indicates improvement.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change daytime activity assessed by actigraphy	Daytime activity level, as evaluated by the number of footsteps, will be assessed by actigraphy, a non-intrusive tool that measures an individual's movement. Mean value from the past 7 days at each timepoint will be evaluated. A positive change from Baseline indicates improvement.	Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)
Change in total cholesterol	Total cholesterol will be measured using standard laboratory techniques. A decrease in total cholesterol is considered an improvement	Baseline, End of intervention (up to Week 4)
Change in high density lipoprotein (HDL)	HDL will be measured from a blood sample using standard laboratory techniques. An increase in HDL is usually considered an improvement.	Baseline, End of intervention (up to Week 4)
Change in low density lipoprotein (LDL)	LDL will be measured from a blood sample using standard laboratory techniques. An decrease in LDL is usually considered an improvement.	Baseline, End of intervention (up to Week 4)
Change in triglycerides	Triglycerides will be measured from a blood sample using standard laboratory techniques. A decrease in triglycerides is considered an improvement.	Baseline, End of intervention (up to Week 4)
Change in Insomnia Severity Index	The insomnia severity index (ISI) measures the frequency of various insomnia symptoms, including prolonged sleep latency, difficulty maintain sleep, early awakening, satisfaction with sleep, interference with the daily activities, if it is noticed by others and if it is causing distress. Each of the seven items is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), resulting in a total score that can range from 0 to 28. A higher score indicates greater insomnia symptoms.	Baseline, End of intervention (up to Week 4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake assessed 3-day food record	Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.	Baseline
Energy intake assessed by 3-day food record	Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.	End of intervention period (up to Week 4)
Satisfaction Survey	Treatment Satisfaction Scale is a 11-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much (6 questions) and also include 5 open ended questions.	End of intervention period (up to Week 4)

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: American Pistachio Growers
• Investigators: Principal Investigator: Emily Lantz, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Midlife women
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 25-0194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data that are not designated as restricted use will be made available as public use data to the research community by request to the PIs. Users of the public use data must agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No