Improving Sleep In Midlife Women

The University of Texas Medical Branch, Galveston72 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Poor Sleep Quality

Interventions

HealthyHabits1BEHAVIORAL

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).

HealthyHabits2BEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Paula Skinkis, M.Ed

CONTACT

409-772-1907 pskinkis@utmb.edu

Emily Lantz, PhD

CONTACT

ejlantz@utmb.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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