Impact of Yo-Yo Sleep on Cardiometabolic Health

Обзор

The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).

Подробное описание

A large portion of the U.S. adult population reports insufficient sleep on a nightly basis. It has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. However, sleep patterns in real life are not consistent over weeks. Individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. The differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. A drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. However, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. Available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (SR) levels. But these studies are short, usually involving only one cycle of SR followed by recovery sleep, and fail to use appropriate and robust statistical methods. Therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. A secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.

Вмешательства

• Поведенческое Intermittent Short Sleep (ISS)
  Restricted sleep duration of \<5.5 h/night for 5 nights (SR) followed by 2 nights of 9.5 hours of time in bed (TIB) (recover sleep) each week.
• Поведенческое Social Jetlag (SJL)
  2-hour delayed sleep timing.
• Поведенческое Sustained Adequate Sleep (SAS)
  Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).

Первичные конечные точки

• Fasting Plasma Glucose [Срок оценки: Up to 4 weeks]
• Insulin Level [Срок оценки: Up to 4 weeks]
• Morning Systolic and Diastolic Blood Pressure [Срок оценки: Up to 4 weeks]
• Evening Systolic and Diastolic Blood Pressure [Срок оценки: Up to 4 weeks]
• Fat mass [Срок оценки: Up to 4 weeks]

Вторичные конечные точки (12)

• Low-density Lipoprotein (LDL) Level [Срок оценки: Up to 4 weeks]
• High-density Lipoprotein (HDL) Level [Срок оценки: Up to 4 weeks]
• Total Cholesterol Level [Срок оценки: Up to 4 weeks]
• Triglyceride Level [Срок оценки: Up to 4 weeks]
• C-reactive protein (CRP) Level [Срок оценки: Up to 4 weeks]
• Interleukin 6 (IL-6) [Срок оценки: Up to 4 weeks]
• Tumor necrosis factor alpha (TNF-alpha) [Срок оценки: Up to 4 weeks]
• Total daily energy expenditure [Срок оценки: Baseline and endpoint (4 weeks)]
• Energy Intake [Срок оценки: Baseline and endpoint (4 weeks)]
• Total Ghrelin [Срок оценки: 2 hours post meal at baseline and endpoint (4 weeks)]
• Serum Leptin [Срок оценки: 2 hours post meal at baseline and endpoint (4 weeks)]
• Adiponectin Level [Срок оценки: Up to 4 weeks]

Критерии участия

Критерии включения

• Aged 18 to 49 years
• BMI 20-29.9 kg/m2
• Habitually sleeping 7-9 hours/night without sleep aids or naps

Критерии исключения

• Sleep disorders
• Psychiatric disorders (including eating disorders) and seasonal affective disorder
• Pregnancy (current/prior year)
• Breastfeeding
• Smokers (Any cigarette smoking or ex-smokers <3years)
• Diabetes
• Elevated blood pressure, taking beta-blockers
• Individuals taking anti-coagulants or anti-platelets
• Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure.
• Travel across time zones; shift work (non-traditional hours)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT05880758 · AAAU3694 · R35HL155670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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