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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05551325
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chronobundle - light — OTHER
    Bright daytime light from 09:00 to 13:00 starting on day 1. The light will be 10,000 lux at 12" and provide a minimal intensity of 1,250 lux at the angle of the eye (30" to 36" distance). The light has a temperature of 5,000 Kelvin indicating a high blue wavelength content which should maximize circadian effects (validated device Sunbox Lighting, Maryland). Following the 09:00 to 13:00 bright light, the room lights will remain on and the curtains will remain open to maximize daytime light exposure while not decreasing bright light tolerance.
  • chronobundle - feeding — OTHER
    For patients receiving enteral feeds, time-restricted (daytime) intermittent feeding will include 4 meals delivered at 08:00, 12:00, 16:00 and 20:00. Each meal will include one-fourth of the recommended daily tube feed volume.
  • chronobundle - mobility — OTHER
    While in the MICU, exercise/mobility sessions led by physical therapy or occupational therapy providers will occur twice daily between 09:00 and 16:00 (i.e., one additional session beyond usual care); intensity will be determined by clinical status and documented in the chart by our physical therapy service. Patients in other hospital locations (e.g., general medical ward post-MICU discharge) will receive one additional session beyond usual care via a study staff-led exercise/mobility session; intensity will be determined by clinical status.
  • chronobundle - sleep — OTHER
    Overnight sleep promotion will occur between 22:00 and 06:00 with a more restricted sleep period between 00:00 and 04:00. This will be achieved by rescheduling non-urgent care. There will be no changes to urgent care. Additionally, room lights will be dimmed, curtains drawn, and room doors closed. Television screens will be fitted with blue light-blocking filters.

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
May 2026
Primary completion
Jun 29, 2029
Completion
Jun 29, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Usual ICU care.
  • Experimental: Chronobundle
    The chronobundle will include bright daytime light, time-restricted intermittent feeding, enhanced exercise/mobility, and overnight sleep promotion.

Primary Outcome Measure

Circadian alignment based on diurnal heart rate variation [ Time Frame: post-treatment, 72 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's CampusNew HavenConnecticut06520-
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York StreetNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus· New Haven, CTYale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street· New Haven, CT

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