Circadian Rhythm Disruption in the Hospital Intensive Care Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-15

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgery Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Elective cardiac surgery

Observation

Intervention Type OTHER

No intervention

Interventions

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Observation

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No