NCT05228444: CircadianCare

Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project

Status unknown NA Last updated 16 November 2022

What this trial tests

NA trial testing CircadianCare in Circadian Rhythm Disorders in 50 participants. Status unknown.

Timeline

28 October 2020

Primary endpoint
28 January 2023

28 January 2023

Quick facts

Lead sponsor	University Hospital Padova
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	28 October 2020
Primary completion	28 January 2023
Estimated completion	28 January 2023
Sites	1 location across Italy

Drugs / interventions tested

• CircadianCare

Conditions studied

• Circadian Rhythm Disorders — all drugs for Circadian Rhythm Disorders →

Sponsor

University Hospital Padova

Who can join

Eligibility, any sex, with Circadian Rhythm Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep is regulated by the interaction of homeostatic and circadian processes. The homeostatic process determines sleep propensity in relation to sleep-wake history, the circadian one is responsible for the alternation of high/low sleep propensity in relation to dark/light cues, and is substantially independent of preceding sleep-wake behaviour. The circadian timing system encompasses a master clock in the brain and peripheral, ancillary time-keepers in virtually every organ of the body.

In recent years, evidence has emerged that circadian disruption has serious medical consequences, including sleep loss, increased cardiovascular morbidity and increased risk of certain types of cancer. Evidence is also emerging that hospitalization per se weakens circadian rhythmicity, due to disease itself and to modified light, food and activity cues.

The aim of our project is to test an inpatient management system (CircadianCare) that limits the circadian impact of hospitalisation by enhancing circadian rhythmicity through an assessment of the patient's specific circadian features/needs and an ad hoc, personalized light-dark, meal and activity schedule to cover the whole of the inpatient stay. This will be compared to standard inpatient management in terms of patients' perception, sleep-wake quality and timing during hospitalisation, inpatient utilization of sleep-inducing medication, length of hospitalisation, and prognosis (i.e. outcome of hospitalisation, subsequent hospitalisations and post-discharge sleep-wake disturbances).

The CircadianCare system is expected to benefit prognosis, decrease costs, and change the way hospitals are organized and designed in future, with potential direct relevance to the plans for the new University Hospital of Padova.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.