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Poor Sleep QualityNCT07337915

Improving Sleep In Midlife Women

A study testing HealthyHabits1, HealthyHabits2 and Snack 2 in people with Poor Sleep Quality, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, women only
Conditions the study is for
Poor Sleep Quality
What is being tested?
HealthyHabits1, HealthyHabits2 and Snack 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
16 Feb 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paula Skinkis, M.Ed contact

409-772-1907

pskinkis@utmb.edu

Emily Lantz, PhD contact

ejlantz@utmb.edu

United States1 site, 1 recruiting
  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Paula Skinkis, M.Ed, 409-772-1907, pskinkis@utmb.edu

    Emily Lantz, PhD, 409-772-0643, ejlantz@utmb.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
HealthyHabits1, HealthyHabits2, Snack 2, Snack 1
Keywords
Midlife women, Sleep, Insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HealthyHabits1Behavioural

    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).

  • HealthyHabits2Behavioural

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

  • Snack 2Other

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

  • Snack 1Other

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

Study groups in NCT07337915
Study groupRoleWhat they receive
Snack 1 + HeathyHabits1OtherParticipants 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).
Receives: Behavioral: HealthyHabits1; Other: Snack 1
Snack 2 + HealthyHabits2OtherParticipants 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.
Receives: Behavioral: HealthyHabits2; Other: Snack 2
Snack 2 + HealthyHabits1OtherParticipants 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).
Receives: Behavioral: HealthyHabits1; Other: Snack 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

Secondary outcomes (23)
  1. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

  2. Change in Body Weight

    Body Weight will be measured using a standardized scale and reported in kg.

    Measured: Baseline, End of intervention period (up to Week 4)

  3. 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.

    Measured: Baseline, End of intervention (up to Week 4)

  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.

    Measured: Baseline, End of intervention period (up to Week 4)

  5. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

  6. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

  7. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

  8. 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.

    Measured: Baseline, End of intervention period (up to Week 4)

  9. 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.

    Measured: Baseline, End of Intervention (Up to Week 4)

  10. Change in visceral fat

    Visceral fat will be measured using dual x-ray absorptiometry. A greater change in visceral fat is considered good.

    Measured: Baseline, End of intervention (up to Week 4)

  11. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  12. 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.

    Measured: Baseline, Post-intervention (Up to Week 5)

  13. 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.

    Measured: Baseline, End of intervention (Up to Week 4), Post-intervention (Up to Week 5)

  14. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  15. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  16. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  17. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  18. 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.

    Measured: Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5)

  19. Change in total cholesterol

    Total cholesterol will be measured using standard laboratory techniques. A decrease in total cholesterol is considered an improvement

    Measured: Baseline, End of intervention (up to Week 4)

  20. 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.

    Measured: Baseline, End of intervention (up to Week 4)

  21. 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.

    Measured: Baseline, End of intervention (up to Week 4)

  22. Change in triglycerides

    Triglycerides will be measured from a blood sample using standard laboratory techniques. A decrease in triglycerides is considered an improvement.

    Measured: Baseline, End of intervention (up to Week 4)

  23. 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.

    Measured: Baseline, End of intervention (up to Week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start16 Feb 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07337915
Sponsor's protocol ID
25-0194
Status last verified
Feb 2026
First submitted
10 Dec 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing HealthyHabits1, HealthyHabits2 and Snack 2 in people with Poor Sleep Quality, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paula Skinkis, M.Ed (409-772-1907, pskinkis@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, End of intervention period (up to Week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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