Clinical trial NCT05402280: Sleep Disturbances and Delirium
Official title: Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: sleep disruptions
delirium
inpatient
sleep protocol
actigraphy
interventions
Lead sponsor: University of Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Ostrava
name: General University Hospital, Prague
First posted: 2022-06-02
Enrollment: 3240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Delirium is a frequent and serious problem in hospitalized patients; it is associated with multiple hospital-acquired complications. There is evidence that the incidence of deliri-um may be minimized by multimodal interventions (pain management, shortening the duration of mechanical ventilation, light sedation, avoiding benzodiazepines, routine delirium monitoring, and early mobilization). Even though a clear association between sleep and delirium has not been established, many studies suggest that sleep disturban-ces may be a key risk factor for the development of delirium. Therefore, sleep promoti-on is becoming an integral part of clinical care. The project support the hypothesis that non-pharmacological preventive interventions promoting sleep (sleep protocol) positive-ly influence the quality of sleep and reduce the incidence of delirium in hospitalized patients. This will be verified by qualitative and quantitative research methods, with the quantitative study being divided into three prospective cross-sectional studies and one interventional study. Data will be obtained from 3240 hospitalized patients by combi-ning subjective methods (questionnaire surveys) and objective measurements (acti-graphy). The project outcomes will allow better understanding of the relationship betwe-en sleep and delirium. A set of non-pharmacological preventive interventions promoting sleep will be developed, with a subsidiary aim to potentially reduce the incidence of delirium in hospitalized patients.

Detailed description: Sleep is one of the most important physiological needs. Sleep disturbances have detri-mental effects on practically all systems and may thus prolong recovery of patients. Studies have documented many similarities between clinical and physiological profiles of patients with delirium and sleep disturbances (ischemia/inflammation, hypoxia, neu-rotransmitter imbalance and tryptophan/melatonin metabolism abnormalities). There is still a lack of strong evidence to support the link between poor sleep and delirium, par-ticularly in hospitalized patients, even though available studies suggest that sleep dis-turbances may be a potential key risk factor for its development, which may have a significant clinical impact. Low awareness of the negative impact of sleep disturbances on the organism and the options for improving sleep may influence the attitude of health professionals to fulfilling this basic human need.The aim of the study is to assess the quality of sleep in patients staying in general wards and intensive care units, identify disruptive factors responsible for its reduced quality, evaluate the relationship between sleep quality and delirium and verify the effectiveness of preventive measures (sleep protocol) in clinical practice. The aims of the study will be met by combining the fol-lowing methods qualitative research, a cross-sectional analytical study and an interven-tional study. The quantitative part of the research will be divided into three consecutive cross-sectional analytical studies. The aim of cross-sectional study I will be to assess the diagnostic properties of the selected instrument (FIRST) for identification of patients predisposed to situational sleep disturbances. This will be immediately followed by cross-sectional study II aimed to identify factors most disrupting sleep of hospitalized patients and, subsequently, by cross-sectional study III subjectively and objectively as-sessing sleep quality and its relationship with delirium, this phase also will be an evalua-tion of routine care (PRE phase), which will be smoothly followed by intervention stud-ies.. The quantitative part is divided into the three cross-sectional studies not only to meet the subgoals and ensure seamless continuity but also because of the patient sam-ple. The patient subgroups are diverse, being specified in detail for each study and se-lected based on the inclusion and exclusion criteria.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* a hospital stay longer than 24 hours
* a hospital stay longer than 36 hours
* hospitalized for at least 72 hours, without previous sleep disturbances, without cognitive impairment

Exclusion Criteria:

* Patients with cognitive impairment preventing them from cooperating
* Glasgow Coma Scale score below 12
* terminal disease
* previous and current treatment for sleep disturbances
* neurocognitive dysfunction (dementia)
* sedative administration over the last 24 hours

Primary outcomes:
measure: Change quality of sleep during hospitalization (subjectively and objectively)
timeFrame: 25 months
Secondary outcomes:
measure: Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
timeFrame: 25 months
measure: Change of the Confusion Assessment Method (CAM)
timeFrame: 25 months
measure: Change of Ford Insomnia Response to Stress Test: FIRST (self-reported)
timeFrame: 4 months
measure: Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported)
timeFrame: 3 months
measure: Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported)
timeFrame: 3 months
measure: Analyse information about concerning the need for sleep
timeFrame: up to 1 months
measure: Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances
timeFrame: up to 1 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University of Ostrava
state: Česká Republika
Study officials:
affiliation: University of Ostrava
name: Darja Jarosova
role: STUDY_DIRECTOR
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