Improving Sleep in Midlife Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: HealthyHabits1 (Behavioral)
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).
干预措施: Snack 1 (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.
干预措施: HealthyHabits2 (Behavioral)
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.
干预措施: Snack 2 (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).
干预措施: HealthyHabits1 (Behavioral)
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).
干预措施: Snack 2 (Other)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, End of intervention period (up to Week 4)
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.
次要结局
- Change in Seated blood pressure(Baseline, End of intervention period (up to Week 4))
- Change in Body Weight(Baseline, End of intervention period (up to Week 4))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance(Baseline, End of intervention (up to Week 4))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment(Baseline, End of intervention period (up to Week 4))
- Change in 24-h Urinary Melatonin(Baseline, End of intervention period (up to Week 4))
- Change in plasma IL-6(Baseline, End of intervention period (up to Week 4))
- Change in sleep health measured by RU-SATED(Baseline, End of intervention period (up to Week 4))
- Change in Psychomotor Vigilance Testing (PVT)(Baseline, End of intervention period (up to Week 4))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue(Baseline, End of Intervention (Up to Week 4))
- Change in visceral fat(Baseline, End of intervention (up to Week 4))
- Change in sleep latency assessed by actigraphy(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in total cholesterol(Baseline, End of intervention (up to Week 4))
- Change in sleep latency assessed by sleep diary(Baseline, Post-intervention (Up to Week 5))
- Change in total sleep time assessed by sleep diary(Baseline, End of intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in total sleep time assessed by actigraphy(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in nocturnal awakenings assessed by actigraphy(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in nocturnal awakenings assessed by sleep diary(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in sleep efficiency assessed by actigraphy(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in high density lipoprotein (HDL)(Baseline, End of intervention (up to Week 4))
- Change in low density lipoprotein (LDL)(Baseline, End of intervention (up to Week 4))
- Change in triglycerides(Baseline, End of intervention (up to Week 4))
- Change daytime activity assessed by actigraphy(Baseline, End of Intervention (Up to Week 4), Post-intervention (Up to Week 5))
- Change in Insomnia Severity Index(Baseline, End of intervention (up to Week 4))