Clinical Trial TitleAlcohol and Circadian Disruption in Shift Workers Decrease Their Resiliency to COVID-19
Clinical Trial Protocol Description:
The purpose of the proposed study is to determine whether misalignment of central circadian rhythms related to shift work in healthcare providers like registered nurses (RNs) and First Responders – (a) increases their risk of coronavirus infection, and (b) is associated with worse clinical outcomes, such as symptom severity and need for hospital admission. We are also proposing to investigate whether alcohol consumption is a moderating factor, which previous data supports may exacerbate the biological effects of circadian misalignment. The rationale for this study is based on several published studies by us and others that have shown that misaligned circadian rhythms decrease immune resiliency, adversely affect lymphocyte trafficking, and increases interleukin 6 (IL-6) production - all of which have been associated with poor outcomes in COVID 19.
A prospectively maintained RedCap database will be created. It will include responses to the electronic RedCap survey that will be distributed to collect data including questions regarding demographics without personal identifiers, race, ethnicity, a past medical and surgical history, a review of systems, allergies and medications, a social history (including substance use, work history and type of shift work) and vital statistics (age, height, weight), and responses to the following questionnaires: food timing questionnaire, the Munich Chronotype Questionnaire (MCTQ), the MCTQ for shift workers (MCTQSHIFT), the Morningness-Eveningness Questionnaire (MEQ), the PROMIS-8 sleep questionnaire, the Alcohol Use Disorder Identification Test (AUDIT), Sleep Hygiene, and a COVID-19 Questionnaire (symptoms and risk factor). The questionnaire set will start with demographic and work history and then series of questions to determine the eligibility of the study subjects including exclusion criteria (ability to read and understand English, pregnancy/breast feeding). If the answer to these questions are negative then the remaining questionnaires will be open to be completed.
The data will be analyzed based on statistical methods listed below to determine significance of association.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a male or female, 18-69 years of age.
- Work as a nurse or first responder as day shift, evening shift, night shift or rotating shift workers in a hospital/out-patient or in the field setting.
You will be excluded from the study if any of the following criteria apply to you:
- Cannot give informed consent.
- Are part of a vulnerable population, including subjects less than 18 years of age, pregnant subjects, subjects who are not fluent in English, and prisoners.
- Are breast feeding, as it can impact circadian oscillation.
- Are a nurse or first responder who does not fit inclusion criteria.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.