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NCT Number: NCT05402280

Sleep Disturbances and Delirium

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.

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Key information

Conditions

Sleep Disturbance Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ostrava

Ostrava, Česká Republika, 70300, Czechia

Location status: Recruiting

Location contact

Jana Slonkova, Ph.D.

SUB_INVESTIGATOR

Karel Sonka, prof.

SUB_INVESTIGATOR

Michaela Rybova

CONTACT

[email protected]

+420608714997

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep protocol

Behavioral

To investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively.

Other names: Sleep promotion protocol

Primary outcomes

  1. Change quality of sleep during hospitalization (subjectively and objectively)

    Time frame: 25 months

    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.

Secondary outcomes

  1. Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

    Time frame: 25 months

    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.

  2. Change of the Confusion Assessment Method (CAM)

    Time frame: 25 months

    The instrument assesses the presence/absence of delirium using four features; delirium is ruled out when none of them is present.

  3. Change of Ford Insomnia Response to Stress Test: FIRST (self-reported)

    Time frame: 4 months

    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.

  4. Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported)

    Time frame: 3 months

    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.

  5. Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported)

    Time frame: 3 months

    Scale used for measuring disturbances factors. Questionnaire contains 23 items divided into 4 dimensions (factors - physical, physiological, environmental and psychological). The ratings use a 1-4 Likert scale. The following ranges are used to grade the severity of sleep disturbances: mild sleep disturbances range 0 - 30, moderate disturbances 31 - 60 and severe disturbances 61 - 92.

  6. Analyse information about concerning the need for sleep

    Time frame: up to 1 months

    Semi-structured interviews with inpatiens.

  7. Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances

    Time frame: up to 1 months

    Semi-structured interviews with nurses.

Study contacts

Contact information is provided by the study sponsor or research team.

Michaela Rybova

CONTACT

[email protected]

+420608714997

Sponsors and collaborators

Lead sponsor

University of Ostrava

Other

Collaborators

  • General University Hospital, Prague
  • University Hospital Ostrava

Registry information

Official study title

Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium

Acronym: SLEEP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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