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

NCT05228444 | Unknown

• 1 other identifier: 150949
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm Disorders

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Diurnal preference

  Short version Munich Chronotype Questionnaire (microMCTQ), measure chronotype based on the midpoint of sleep.

  first day

• 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

• 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 Outcomes (2)

• Monitoring environment temperature

  first, 7th 14th day

• Monitoring environment noise

  first, 7th 14th day

Study Arms (2)

Circadiancare

EXPERIMENTAL

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.

Behavioral: CircadianCare

Control

NO INTERVENTION

Interventions

CircadianCare BEHAVIORAL

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.

Circadiancare

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients

You may not qualify if:

• absence of compliance

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Padova University Hospital

Padua, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Sara Montagnese

CONTACT

+390498218675; sara.montagnese@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 8, 2022
• Study Start: October 28, 2020
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)