Clinical trial NCT05228444: Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
Official title: Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circadian Rhythm Disorders
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

• Hospitalized patients

Exclusion Criteria:

• absence of compliance

Primary outcomes:
measure: Change in sleep onset latency - actigraphy
timeFrame: first, 7th and 14 day
measure: Change in sleep onset latency - sleep diary
timeFrame: first, 7th and 14 day
measure: Change in sleep duration - actigraphy
timeFrame: first, 7th and 14 day
measure: Change in sleep duration - sleep diary
timeFrame: first, 7th and 14 day
measure: Change in sleep awakening - actigraphy
timeFrame: first, 7th and 14 day
measure: Change in sleep awakening - sleep diary
timeFrame: first, 7th and 14 day
measure: Change in sleep efficiency - actigraphy
timeFrame: first, 7th and 14 day
measure: Change in sleep efficiency - sleep diary
timeFrame: first, 7th and 14 day
measure: Actigraphy - change in fragmentation of activity-rest periods
timeFrame: 14 days
measure: Actigraphy - change in sleep regularity over days
timeFrame: 14 days
measure: Change in daytime sleepiness
timeFrame: first day then again at 7th and 14th day
measure: Salivary melatonin shift
timeFrame: baseline DLMO and then again at 7th and 14th day
measure: Diurnal preference
timeFrame: first day
measure: Assess circadian preference
timeFrame: first day
measure: Sleep quality
timeFrame: first day
Secondary outcomes:
measure: Monitoring environment temperature
timeFrame: first, 7th 14th day
measure: Monitoring environment noise
timeFrame: first, 7th 14th day
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Padova University Hospital
Study officials:
References: