Clinical trial NCT03514953: The Impact of Physical (In)Activity on Sleep Quality
Official title: The Impact of Physical (In)Activity on Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed research will examine the role of physical activity (PA) on altering sleep quality (SQ) while systematically examining novel mechanisms that may drive changes in SQ. Specifically, the study will examine how a 2 week reduction in PA alters sleep quality in young, healthy individuals. Additionally, during this reduction in PA, the study will examine changes in inflammation, oxidative stress, and sympathetic activity to identify potential mechanisms for alterations in sleep quality.

Detailed description: Sleep, which makes up approximately one third of an individual's life, plays a vital role in normal bodily functioning by regulating metabolic and endocrine function. Disturbed sleep, defined as any alteration to normal sleep patterns, is highly prevalent, affecting 35% and 41% of the general population in the United States and has been linked to poor cardiovascular health, diabetes, obesity, dyslipidemia, and hypertension. Young adults are a population at high risk for disturbed sleep-related health outcomes due to negative lifestyle behaviors such as alcohol consumption, drug use, study patterns, and excessive screen time that remain with advancing age. Due to the importance of improving or maintaining health outcomes through adequate sleep quality (SQ), the proposed research will examine the role of physical activity (PA) on altering SQ while systematically examining novel mechanisms that may drive changes in SQ. Specifically, this study will examine how alterations (increases and decreases) in PA impact SQ and how these alterations modify inflammation, oxidative stress, and sympathetic stimulation in young adults.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals with average weekly step count greater than 7500
* Low risk of cardiovascular, pulmonary, and metabolic disease

Exclusion Criteria:

* Individuals with cardiovascular, pulmonary, and metabolic disease
* Individuals taking medications that may affect cardiovascular, pulmonary, and metabolic function
* Diet differs substantially from typical diet, significant calorie restriction, or vitamin/mineral deficiencies
* Pregnant women
* Prisoners

Primary outcomes:
measure: Change in sleep quality (phase 1)
timeFrame: Day 7 to Day 21
measure: Change in sleep quality (phase 2)
timeFrame: Day 21 to Day 28
Secondary outcomes:
measure: Level of Tumor Necrosis Factor Alpha in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Level of Interleukin-6 in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Level of Interleukin-1 in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Level of Norepinephrine in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Level of Epinephrine in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Level of Lipid peroxidation in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Protein oxidation in blood
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Change in Lower Limb Vascular Function
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Change in Upper Limb Vascular Function
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
measure: Change in Leg Vascular Function
timeFrame: Measured on Day 7, Day 14, Day 21, Day 28
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ryan Garten, PhD
role: PRINCIPAL_INVESTIGATOR
References: