Improving Sleep In Midlife Women

NCT ID: NCT07337915

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Poor Sleep Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type OTHER

HealthyHabits1

Intervention Type BEHAVIORAL

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).

Snack 1

Intervention Type OTHER

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

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.

Group Type OTHER

HealthyHabits2

Intervention Type BEHAVIORAL

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

Snack 2

Intervention Type OTHER

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

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).

Group Type OTHER

HealthyHabits1

Intervention Type BEHAVIORAL

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).

Snack 2

Intervention Type OTHER

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

Interventions

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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).

Intervention Type BEHAVIORAL

HealthyHabits2

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

Intervention Type BEHAVIORAL

Snack 2

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

Intervention Type OTHER

Snack 1

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Pistachio Growers

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Lantz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Paula Skinkis, M.Ed

Role: CONTACT

409-772-1907

Emily Lantz, PhD

Role: CONTACT

Facility Contacts

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Paula Skinkis, M.Ed

Role: primary

409-772-1907

Emily Lantz, PhD

Role: backup

409-772-0643

Other Identifiers

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25-0194

Identifier Type: -

Identifier Source: org_study_id

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