RECRUITING

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

Official Title

Reestablishing Sleep and Circadian Alignment in Medically Critically Ill Patients Via a Mechanistic Randomized Controlled Trial (RCT) of an Intensive Care Unit (ICU) Sleep Chronobundle

Quick Facts

Study Start:2024-05-13
Study Completion:2028-06-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05551325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Melissa P Knauert, MD, PhD
CONTACT
203-785-4163
melissa.knauert@yale.edu

Principal Investigator

Melissa P Knauert, MD, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus
New Haven, Connecticut, 06520
United States
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Melissa P Knauert, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-13
Study Completion Date2028-06-29

Study Record Updates

Study Start Date2024-05-13
Study Completion Date2028-06-29

Terms related to this study

Keywords Provided by Researchers

  • critical illness
  • sleep deficiency
  • circadian misalignment

Additional Relevant MeSH Terms

  • Critical Illness
  • Sleep Deprivation
  • Circadian Rhythm Sleep Disorder, Unspecified