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

Circadian Rhythm Disorders Clinical Trial

— CircadianCare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228444
• Other study ID #: 150949
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: January 28, 2023

Study information

• Verified date: November 2022
• Source: University Hospital Padova
• Contact: Sara Montagnese
• Phone: +390498218675
• Email: sara.montagnese[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitalized patients

Exclusion Criteria:

• absence of compliance

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders

Intervention

Behavioral:
• CircadianCare
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.

Locations

Country	Name	City	State
Italy	Padova University Hospital	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep onset latency - actigraphy	Sleep latency (number of minutes between try to sleep and sleep onset, SL) is objectively assessed by wrist actigraphy device. SL > 30 min is considered clinically significant. (scale minutes)	first, 7th and 14 day
Primary	Change in sleep onset latency - sleep diary	The number of minutes between try to sleep and sleep onset as measured by sleep diary. Sleep latency > 30 min is considered clinically significant. (scale minutes)	first, 7th and 14 day
Primary	Change in sleep duration - actigraphy	Total sleep time (TST) is calculated as hours per night spent sleeping while in bed after light off. It is objectively assessed by wrist actigraphy device. (scale hours)	first, 7th and 14 day
Primary	Change in sleep duration - sleep diary	Total sleep time (TST) is calculated as hours per night spent sleeping while in bed after light off. It is assessed using daily sleep diaries. (scale hours)	first, 7th and 14 day
Primary	Change in sleep awakening - actigraphy	Measured with wrist actigraphy, wake after sleep onset (WASO) is the number of minutes scored as wake from sleep onset until the end of the last sleep episode while in bed. (scale minutes)	first, 7th and 14 day
Primary	Change in sleep awakening - sleep diary	Measured with sleep diary. Wake after sleep onset (WASO) is a subjective measure of participants' sleeping and waking times in which time awake expressed in minutes after sleep onset is obtained.	first, 7th and 14 day
Primary	Change in sleep efficiency - actigraphy	Measured with wrist actigraphy, sleep efficiency (SE) is the percentage of time (0%-100%) the participant was sleeping from sleep onset (defined as the first 20 continuous minutes of sleep after getting into bed) until the last minute scored as sleep (the following morning).	first, 7th and 14 day
Primary	Change in sleep efficiency - sleep diary	Measured with sleep diary. The sleep efficiency is a subjective measure of participants' sleeping and waking times, from which sleep efficiency is computed as the quota between time sleeping/time spent in bed, expressed in percentage.	first, 7th and 14 day
Primary	Actigraphy - change in fragmentation of activity-rest periods	Interdaily variability (IV) quantifies the degree of fragmentation. The variable has a theoretical range of 0 to 2 with higher values indicating higher fragmentation. Typical values for healthy subjects will be below 1.	14 days
Primary	Actigraphy - change in sleep regularity over days	Intradaily stability (IS) quantifies the degree of regularity in the activity-rest pattern with a range of 0 to 1 where a value of 0 indicates a total lack of rhythm and a value of 1 indicates a perfectly stable rhythm.	14 days
Primary	Change in daytime sleepiness	Karolinska Sleepiness Scale (KSS) comprises a single item assessing state sleepiness at a particular time (every hour) during the day on a scale from 1 (very rested) to 9 (very sleepy).	first day then again at 7th and 14th day
Primary	Salivary melatonin shift	A change in the timing of the circadian system is measured using the Dim Light Melatonin Onset (DLMO), gold standard for measuring human circadian phase. Salivary melatonin is measured five times every 1h before usual bedtime and assayed using standard commercially-available radioimmunoassay (RIA) kits. The time at which melatonin rises above a 4 pg/mL threshold is the DLMO.	baseline DLMO and then again at 7th and 14th day
Primary	Diurnal preference	Short version Munich Chronotype Questionnaire (microMCTQ), measure chronotype based on the midpoint of sleep.	first day
Primary	Assess circadian preference	Morning-evening questionnaire (MEQ) scale: MEQ sum score, range: 16-86, participants are classified as Morning-types (scores between 59 and 86), Neither-types (scores between 42 and 58), and Evening-types (scores between 16 and 41).	first day
Primary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI) scale: global PSQI score, range: 0 - 21, scores of 5 or higher indicate poor sleep quality.	first day
Secondary	Monitoring environment temperature	Temperature levels within ward rooms will be monitored at regular intervals by ibutton temperature sensors, using the Celsius scale.	first, 7th 14th day
Secondary	Monitoring environment noise	Noise levels within ward rooms will be monitored at regular intervals by phonometers. Noise level is measured in decibels (dB)	first, 7th 14th day