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Completed

NCT Number: NCT03498560

Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Over 60 years of age
  • Inpatient and scheduled for surgical procedure at MGH

Exclusion criteria

  • Blindness, deafness or the inability to speak English
  • Inability to provide informed consent

Objective Drop Criteria

  • Post-operative intubation greater than 24 hours

Treatment and study plan

PSG

Device

PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Primary outcomes

  1. Association Between Sleep and POD

    Time frame: Night before surgery, approximately 13 hours

    Duration of sleep in delirious vs non-delirious patients

Secondary outcomes

  1. Burst Suppression Ratio

    Time frame: Length of surgery (2-12 hours)

    Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Mar 31, 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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