Improving Sleep In Midlife Women

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.

In-office diastolic and systolic blood pressure will be measured using standard equipment. Blood pressure will be measures in mmHg.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

HDL will be measured from a blood sample using standard laboratory techniques. An increase in HDL is usually considered an improvement.

LDL will be measured from a blood sample using standard laboratory techniques. An decrease in LDL is usually considered an improvement.

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

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.

Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.

Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.

Treatment Satisfaction Scale is a 11-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much (6 questions) and also include 5 open ended questions.