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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07691996

Enrollment

Registered

2026-07-09

Start date

2026-09-01

Completion date

2028-01-01

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, ICU, ICU Hospitalization, Melatonin, Sleep

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.

Interventions

DRUGMelatonin

patients in this arm will recieve melatonin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Sleep Efficiency as measured by total sleep time over time in bed	From enrollment to the end of 48 hours of the last subject's participation in the study	These measures are obtained from the sleep profiler. Higher sleep efficiency is better.
, Total sleep time in hours and minutes	From enrollment to the end of 48 hours of the last subject's participation in the study	These measures are obtained from the sleep profiler.
, Delta to Theta ratio	From enrollment to the end of 48 hours of the last subject's participation in the study	These measures are obtained from the sleep profiler Higher delta to Theta ratio is better
, Arousal Index	From enrollment to the end of 48 hours of the last subject's participation in the study	These measures are obtained from the sleep profiler. Lower arousal index is better

Contacts

CONTACTJag Sunderram, MD

sunderja@rwjms.rutgers.edu732-235-7038

PRINCIPAL_INVESTIGATORJag Sunderram

Rutgers Robert Wood Johnson Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026