Sleep Disturbances and Delirium
ConditionSleep Disturbance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ostrava
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with cognitive impairment preventing them from cooperating
Glasgow Coma Scale score below 12
terminal disease
previous and current treatment for sleep disturbances
Trial design
Design model
Crossover
Treatments tested in this trial
Sleep protocol
BehavioralTo investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively.
Treatment groups
3,240 Participants
are divided into 4 treatment groupsGroup A: Qualitative studyNo intervention 0 interventions
Group B: Prospective quantitative studyNo intervention 0 interventions
Group C: Retrospective quantitative studyNo intervention 0 interventions
Group D: Interventional studyOther 1 intervention
Trial outcomes
Primary outcomes
1
Change quality of sleep during hospitalization (subjectively and objectively)
Assessment of quality of sleep using Richards Campbell Sleep Questionnaire (RCSQ) five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in patients. The RCSQ contains 5 items (sleep depth, sleep latency, awakenings, returning to sleep and sleep quality) plus noise as an optional item (evaluated separately). Each item is scored by using a 0-100 visual analogue scale. The total score is calculated as the mean of all items, with 0 and 100 representing the worst and best sleep, respectively. Objectively sleep were assed by actigraphy -the method collects and stores data generated by patient movements.
Time frame
25 monthsSecondary outcomes
1
Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
This is a two-step assessment of delirium. The first step is to assess arousal with the Richmond Agitation and Sedation Scale. The second step is assessment of the presence/absence of delirium using four features; delirium is ruled out when none of them is present.
Time frame
25 months2
Change of the Confusion Assessment Method (CAM)
The instrument assesses the presence/absence of delirium using four features; delirium is ruled out when none of them is present.
Time frame
25 months3
Change of Ford Insomnia Response to Stress Test: FIRST (self-reported)
The instrument comprises 9 items (scenarios) to identify individuals predisposed to situational sleep disturbances. The FIRST consists of 9 items which are scored on a four point-scale. High scores are indicative of greater vulnerability to sleep disruption. Total FIRST scores range from 9 to 36.
Time frame
4 months4
Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported)
The most widely used instrument for assessing factors causing sleep disturbances in the ICU. The final version contains 27 items divided into 4 dimensions (sleep quality, daytime sleepiness, disruptive factors produce by the healthcare team and environmental disruptive factors). The ratings use a 1-10 Likert scale.
Time frame
3 monthsSponsors and contacts
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University of Ostrava
Lead sponsor
University Hospital Ostrava
Collaborator
General University Hospital, Prague
Collaborator
Source ClinicalTrials.gov