Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project (CircadianCare)
Primary Purpose
Circadian Rhythm Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CircadianCare
Sponsored by
About this trial
This is an interventional treatment trial for Circadian Rhythm Disorders
Eligibility Criteria
Inclusion Criteria:
• Hospitalized patients
Exclusion Criteria:
• absence of compliance
Sites / Locations
- Padova University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Circadiancare
Control
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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.
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).
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.
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.
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.
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).
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.
Diurnal preference
Short version Munich Chronotype Questionnaire (microMCTQ), measure chronotype based on the midpoint of sleep.
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).
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) scale: global PSQI score, range: 0 - 21, scores of 5 or higher indicate poor sleep quality.
Secondary Outcome Measures
Monitoring environment temperature
Temperature levels within ward rooms will be monitored at regular intervals by ibutton temperature sensors, using the Celsius scale.
Monitoring environment noise
Noise levels within ward rooms will be monitored at regular intervals by phonometers. Noise level is measured in decibels (dB)
Full Information
NCT ID
NCT05228444
First Posted
January 10, 2022
Last Updated
November 15, 2022
Sponsor
University Hospital Padova
1. Study Identification
Unique Protocol Identification Number
NCT05228444
Brief Title
Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
Acronym
CircadianCare
Official Title
Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
January 28, 2023 (Anticipated)
Study Completion Date
January 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Padova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circadiancare
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CircadianCare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sleep onset latency - actigraphy
Description
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)
Time Frame
first, 7th and 14 day
Title
Change in sleep onset latency - sleep diary
Description
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)
Time Frame
first, 7th and 14 day
Title
Change in sleep duration - actigraphy
Description
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)
Time Frame
first, 7th and 14 day
Title
Change in sleep duration - sleep diary
Description
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)
Time Frame
first, 7th and 14 day
Title
Change in sleep awakening - actigraphy
Description
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)
Time Frame
first, 7th and 14 day
Title
Change in sleep awakening - sleep diary
Description
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.
Time Frame
first, 7th and 14 day
Title
Change in sleep efficiency - actigraphy
Description
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).
Time Frame
first, 7th and 14 day
Title
Change in sleep efficiency - sleep diary
Description
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.
Time Frame
first, 7th and 14 day
Title
Actigraphy - change in fragmentation of activity-rest periods
Description
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.
Time Frame
14 days
Title
Actigraphy - change in sleep regularity over days
Description
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.
Time Frame
14 days
Title
Change in daytime sleepiness
Description
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).
Time Frame
first day then again at 7th and 14th day
Title
Salivary melatonin shift
Description
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.
Time Frame
baseline DLMO and then again at 7th and 14th day
Title
Diurnal preference
Description
Short version Munich Chronotype Questionnaire (microMCTQ), measure chronotype based on the midpoint of sleep.
Time Frame
first day
Title
Assess circadian preference
Description
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).
Time Frame
first day
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) scale: global PSQI score, range: 0 - 21, scores of 5 or higher indicate poor sleep quality.
Time Frame
first day
Secondary Outcome Measure Information:
Title
Monitoring environment temperature
Description
Temperature levels within ward rooms will be monitored at regular intervals by ibutton temperature sensors, using the Celsius scale.
Time Frame
first, 7th 14th day
Title
Monitoring environment noise
Description
Noise levels within ward rooms will be monitored at regular intervals by phonometers. Noise level is measured in decibels (dB)
Time Frame
first, 7th 14th day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Hospitalized patients
Exclusion Criteria:
• absence of compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Montagnese
Phone
+390498218675
Email
sara.montagnese@unipd.it
Facility Information:
Facility Name
Padova University Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Montagnese
Phone
+390498218675
Email
sara.montagnese@unipd.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
We'll reach out to this number within 24 hrs