Improving Sleep In Midlife Women

Официальное название

Improving Sleep in Midlife Women

Обзор

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.

Вмешательства

• Поведенческое 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).
• Поведенческое HealthyHabits2
  Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.
• Другое Snack 2
  Participants in this group will consume 2 servings of pistachios daily for 30 days
• Другое Snack 1
  Participants in the group will consume 2 servings of potato chips daily for 30 days.

Первичные конечные точки

• Change in Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, End of intervention period (up to Week 4)]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Texas Medical Branch — Galveston

Идентификаторы

NCT: NCT07337915 · 25-0194

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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