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Sleep Disturbances and Delirium (SLEEP)

Primary Purpose

Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Sleep protocol
Sponsored by
University of Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring sleep disruptions, delirium, inpatient, sleep protocol, actigraphy, interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

Other

Arm Label

Qualitative study

Prospective quantitative study

Retrospective quantitative study

Interventional study

Arm Description

15 nurses (direct care nurses, nurse managers) and 5 patients, to investigate experiences and compare attitudes and opinions concerning the need for and quality of sleep in hospitalized patients.

diagnosing predisposition to sleep disturbances: 400 inpatients staying in gene-ral wards: Patients will undergo a serial of structured and standardized questi-onnaires during scheduled: FIRST: on the day of admission and RCSQ during their hospital stay (record length of up to 7 days).

subjective assessment of factors affecting sleep: 600 hospitalized patients (360 patients in general wards, 240 patients in intensive care wards). On the day of discharge, patients will retrospectively assess disruptive factors that could in-fluence the quality of their sleep during their hospital stay by standardized que-stionnaire.

(subjective and objective assessment of sleep, quality of sleep with respect to delirium, baseline - routine care: PRE phase) implementation of sleep protocol and assess effectiveness (POST phase: determining the effectiveness of imple-mented sleep measures): overal: 2240 patients (1480 general ward, 760 inten-sive care wards.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported)
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.
Analyse information about concerning the need for sleep
Semi-structured interviews with inpatiens.
Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances
Semi-structured interviews with nurses.

Full Information

First Posted
May 19, 2022
Last Updated
September 18, 2023
Sponsor
University of Ostrava
Collaborators
University Hospital Ostrava, General University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05402280
Brief Title
Sleep Disturbances and Delirium
Acronym
SLEEP
Official Title
Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ostrava
Collaborators
University Hospital Ostrava, General University Hospital, Prague

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
sleep disruptions, delirium, inpatient, sleep protocol, actigraphy, interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
3240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qualitative study
Arm Type
No Intervention
Arm Description
15 nurses (direct care nurses, nurse managers) and 5 patients, to investigate experiences and compare attitudes and opinions concerning the need for and quality of sleep in hospitalized patients.
Arm Title
Prospective quantitative study
Arm Type
No Intervention
Arm Description
diagnosing predisposition to sleep disturbances: 400 inpatients staying in gene-ral wards: Patients will undergo a serial of structured and standardized questi-onnaires during scheduled: FIRST: on the day of admission and RCSQ during their hospital stay (record length of up to 7 days).
Arm Title
Retrospective quantitative study
Arm Type
No Intervention
Arm Description
subjective assessment of factors affecting sleep: 600 hospitalized patients (360 patients in general wards, 240 patients in intensive care wards). On the day of discharge, patients will retrospectively assess disruptive factors that could in-fluence the quality of their sleep during their hospital stay by standardized que-stionnaire.
Arm Title
Interventional study
Arm Type
Other
Arm Description
(subjective and objective assessment of sleep, quality of sleep with respect to delirium, baseline - routine care: PRE phase) implementation of sleep protocol and assess effectiveness (POST phase: determining the effectiveness of imple-mented sleep measures): overal: 2240 patients (1480 general ward, 760 inten-sive care wards.
Intervention Type
Behavioral
Intervention Name(s)
Sleep protocol
Other Intervention Name(s)
Sleep promotion protocol
Intervention Description
To investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively.
Primary Outcome Measure Information:
Title
Change quality of sleep during hospitalization (subjectively and objectively)
Description
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 months
Secondary Outcome Measure Information:
Title
Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Description
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 months
Title
Change of the Confusion Assessment Method (CAM)
Description
The instrument assesses the presence/absence of delirium using four features; delirium is ruled out when none of them is present.
Time Frame
25 months
Title
Change of Ford Insomnia Response to Stress Test: FIRST (self-reported)
Description
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 months
Title
Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported)
Description
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 months
Title
Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported)
Description
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.
Time Frame
3 months
Title
Analyse information about concerning the need for sleep
Description
Semi-structured interviews with inpatiens.
Time Frame
up to 1 months
Title
Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances
Description
Semi-structured interviews with nurses.
Time Frame
up to 1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Rybova
Phone
+420608714997
Email
michaela.rybova@osu.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darja Jarosova
Organizational Affiliation
University of Ostrava
Official's Role
Study Director
Facility Information:
Facility Name
University of Ostrava
City
Ostrava
State/Province
Česká Republika
ZIP/Postal Code
70300
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Rybova
Phone
+420608714997
Email
michaela.rybova@osu.cz
First Name & Middle Initial & Last Name & Degree
Karel Sonka, prof.
First Name & Middle Initial & Last Name & Degree
Jana Slonkova, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
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Sleep Disturbances and Delirium

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