Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU

NCT07691996 | Not Yet Recruiting Phase 4

• 1 other identifier: Pro2025002445
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.

Conditions

ICU; ICU Hospitalization; Melatonin; Sleep; Critical Illness

Outcome Measures

Primary Outcomes (4)

• Sleep Efficiency as measured by total sleep time over time in bed

  These measures are obtained from the sleep profiler. Higher sleep efficiency is better.

  From enrollment to the end of 48 hours of the last subject's participation in the study

• , Total sleep time in hours and minutes

  These measures are obtained from the sleep profiler.

  From enrollment to the end of 48 hours of the last subject's participation in the study

• , Delta to Theta ratio

  These measures are obtained from the sleep profiler Higher delta to Theta ratio is better

  From enrollment to the end of 48 hours of the last subject's participation in the study

• , Arousal Index

  These measures are obtained from the sleep profiler. Lower arousal index is better

  From enrollment to the end of 48 hours of the last subject's participation in the study

Study Arms (1)

Melatonin arm

EXPERIMENTAL

3mg Melatonin will be administered orally to all subjects.

Drug: Melatonin

Interventions

Melatonin DRUG

patients in this arm will recieve melatonin

Melatonin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, admitted to the ICU
• Expected length of stay of at least 48 hours
• Not mechanically ventilated
• Able to take oral medications.
• Hemodynamically stable as determined by the treating ICU physician
• Able to provide informed consent or have consent provided by a legally -authorized representative.

You may not qualify if:

• Mechanically ventilated
• Currently using melatonin prior to ICU admission,
• Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.
• Pregnant or lactating individuals
• Those individuals with a comfort measures-only status

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Critical Illness

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jag Sunderram

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jag Sunderram, MD

CONTACT

732-235-7038; sunderja@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share