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OpenTrials
Completed

NCT Number: NCT01433315

Physiologic Effects of Sleep Restriction

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the physiologic effects of sleep restriction. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-40 years
  • No chronic medical conditions other than seasonal or environmental allergies
  • On no prescription medications other than second generation antihistamines (Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices.
  • BMI 18.5-35 kg/m2
  • Both normotensive and prehypertensive people are eligible and will be studied
  • Not a current smoker or tobacco user
  • Not pregnant or breast feeding and not intending to become pregnant or breast feed

Exclusion criteria

  • The investigators will exclude subjects who have any medical or psychiatric disorders
  • History of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives.
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded. Current smokers will be excluded.
  • All female subjects will undergoing a screening pregnancy test and excluded if positive.
  • Subjects found to have significant sleep disorders will be excluded.

Treatment and study plan

Sleep Restriction

Behavioral

restricted sleep

Primary outcomes

  1. Change in blood pressure

    Time frame: throughout 16 days

    Change in mean arterial blood pressure over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.

Secondary outcomes

  1. Change in catecholamines

    Time frame: throughout 16 days

    Change in catecholamines, measured during acclimation, experimental, and recovery

  2. Change in endothelial function

    Time frame: throughout 16 days

    Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.

  3. Change in baroreflex sensitivity

    Time frame: throughout 16 days

    Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery

  4. Change in arterial stiffness

    Time frame: throughout 16 days

    Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.

  5. Change in electrocardiographic characteristics

    Time frame: throughout 16 days

    Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.

  6. Change in markers of inflammation

    Time frame: throughout 16 days

    Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.

  7. Change in fat tissue characteristics

    Time frame: throughout 16 days

    Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.

Other outcomes

  1. Change in sleep architecture and sleepiness

    Time frame: throughout 16 days

    Change in sleep architecture and sleepiness, measured during acclimation, experimental, and recovery timepoints.

  2. Change in neurocognitive function

    Time frame: throughout 16 days

    Change in neurocognitive function, measured during acclimation, experimental, and recovery timepoints

  3. Change in cardiovascular reactivity

    Time frame: throughout 16 days

    Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2011
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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