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Clinical Trial NCT05402280 (SLEEP) for Sleep Disturbance is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Sleep Disturbances and Delirium (SLEEP) 3,240 Preventive
Clinical Trial NCT05402280 (SLEEP) is an interventional study for Sleep Disturbance that is recruiting. It started on 1 May 2022 with plans to enroll 3,240 participants. Led by University of Ostrava, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 25 February 2025.
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 associa...Show More
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). T...Show More
Official Title
Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium
Conditions
Sleep DisturbancePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- SLEEP
NCT ID Number
Start Date (Actual)
2022-05-01
Last Update Posted
2025-02-25
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
3,240
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
sleep disruptions
delirium
inpatient
sleep protocol
actigraphy
interventions
delirium
inpatient
sleep protocol
actigraphy
interventions
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionQualitative study 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. | N/A |
No InterventionProspective quantitative study 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). | N/A |
No InterventionRetrospective quantitative study 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. | N/A |
OtherInterventional study (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. | Sleep protocol To investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 25 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 25 months |
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. | 25 months |
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. | 4 months |
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. | 3 months |
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. | 3 months |
Analyse information about concerning the need for sleep | Semi-structured interviews with inpatiens. | up to 1 months |
Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances | Semi-structured interviews with nurses. | up to 1 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
University of Ostrava- University Hospital Ostrava
- General University Hospital, Prague
Study Central Contact
Contact: Michaela Rybova, +420608714997, [email protected]
1 Study Locations in 1 Countries
Česká Republika
University of Ostrava, Ostrava, Česká Republika, 70300, Czechia
Michaela Rybova, Contact, +420608714997, [email protected]
Karel Sonka, prof., Sub-Investigator
Jana Slonkova, Ph.D., Sub-Investigator
Recruiting