Circadian Rhythm Disruption in the Hospital Intensive Care Environment

N/AActive Not RecruitingNCT05828680

University of Pennsylvania15 enrolled

Overview

Abrupt changes to one's lifestyle disrupt biorhythms. Acute effects are well known from jet lag where transmeridian travel leads to insomnia, fatigue, irritability, gastrointestinal symptoms and other complaints. Several studies in the hospital environment reported dampened and misaligned biorhythms, suggesting that the inpatient experience is replete with circadian disruptors. However, comprehensive assessments of how circadian clocks are affected in intensive care and how this predicts post-operative recovery and risk are largely missing.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Surgery Cardiovascular Diseases

Interventions

ObservationOTHER

No intervention

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Adults scheduled for cardiac surgery; * ≥18 years of age; * Capable of giving informed consent; * Own a smartphone (Apple devices only). Exclusion Criteria: * Taking sleep aids (antihistamines, melatonin, etc.) * History of alcohol abuse (more than 2 drinks a day with last drink within the past 3 days) * History of substance abuse at risk of postoperative withdrawal; * Active diagnosis of alcohol or substance abuse; * Recent travel across more than two (2) time zones (within the past month); * Planned travel across more than two (2) time zones during the planned study activities; * Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; * Subjects without access to WiFi in their or close to home or at work; * Patients with hearing aids; * Heart transplant patients; * Patients in isolation.

Outcomes

Primary Outcomes

Sleep depth

Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)

Time frame: Up to 48 hours

Secondary Outcomes

Odds Ratio Product-based sleep depth

Variance in sleep depth assessed as Odds Ratio Product (ORP) which ranges between ORP=0 (deeply asleep) and ORB=2.5 (fully awake).

Time frame: Up to 48 hours

Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

Variance in cognitive function

Time frame: Up to 24 hours

Number of recorded patient visits

Any patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends are documented

Time frame: 24 hours

Purpose of recorded patient visits

The rationale is documented descriptively for each patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends