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

NCT ID: NCT05228444

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2023-01-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Circadiancare

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.

Group Type: EXPERIMENTAL

CircadianCare

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Hospitalized patients

Exclusion Criteria

• absence of compliance

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Padova

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Sara Montagnese

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Padova University Hospital

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sara Montagnese

Role: CONTACT

sara.montagnese@unipd.it

+390498218675

Facility Contacts

Sara Montagnese

Role: primary

sara.montagnese@unipd.it

+390498218675

Other Identifiers

150949

Identifier Type: -

Identifier Source: org_study_id