Clinical trial NCT05828680: Circadian Rhythm Disruption in the Hospital Intensive Care Environment
Official title: Circadian Rhythm Disruption in the Hospital Intensive Care Environment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery
Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential patients will be screened from outpatient clinic schedules from cardiac surgery appointments within the Perelman Center for Advanced Medicine. Patients for whom cardiac surgery is advised and who meet eligibility criteria will be approached and enrolled after their consultation with the surgeon.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep depth
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Odds Ratio Product-based sleep depth
timeFrame: Up to 48 hours
measure: Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Up to 24 hours
measure: Number of recorded patient visits
timeFrame: 24 hours
measure: Purpose of recorded patient visits
timeFrame: 24 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carsten Skarke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Garret A FitzGerald, MD
role: PRINCIPAL_INVESTIGATOR
References: