Physiologic Effects of Sleep Restriction

NCT01433315 | Completed

• 1 other identifier: 11-002121
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Deprivation

Keywords

sleep deprivation; sleep restriction

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

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

  throughout 16 days

Secondary Outcomes (7)

• Change in catecholamines

  throughout 16 days

• Change in endothelial function

  throughout 16 days

• Change in baroreflex sensitivity

  throughout 16 days

• Change in arterial stiffness

  throughout 16 days

• Change in electrocardiographic characteristics

  throughout 16 days

Other Outcomes (3)

• Change in sleep architecture and sleepiness

  throughout 16 days

• Change in neurocognitive function

  throughout 16 days

• Change in cardiovascular reactivity

  throughout 16 days

Study Arms (2)

sleep restriction

EXPERIMENTAL

restricted sleep during the experimental period

Behavioral: sleep restriction

normal sleep

NO INTERVENTION

normal sleep during the experimental period

Interventions

sleep restriction BEHAVIORAL

restricted sleep

sleep restriction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Virend K Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: September 13, 2011
• Study Start: October 1, 2011
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

US (1)