Cardiovascular Diseases, Surgery
Conditions
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.
Interventions
OTHERObservation
No intervention
Sponsors
University of Pennsylvania
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep depth | Up to 48 hours | Variance in sleep depth assessed as percent REM sleep of total sleep time (TST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Odds Ratio Product-based sleep depth | Up to 48 hours | Variance in sleep depth assessed as Odds Ratio Product (ORP) which ranges between ORP=0 (deeply asleep) and ORB=2.5 (fully awake). |
| Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) | Up to 24 hours | Variance in cognitive function |
| Number of recorded patient visits | 24 hours | Any patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends are documented |
| Purpose of recorded patient visits | 24 hours | The rationale is documented descriptively for each patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarsten Skarke, MD
University of Pennsylvania
PRINCIPAL_INVESTIGATORGarret A FitzGerald, MD
University of Pennsylvania
Outcome results
None listed