Sleep Disturbance Clinical Trial
Official title:
Impact of the Use a Multifaceted Intervention of Environment Control in the ICU to Optimize Quantity and Quality of Sleep in Critically Ill Patients
In critically ill patients, sleep and circadian rhythms are markedly disturbed, including sleep deprivation and disruption, as well as altered sleep architecture, and loss of normal oscillations of Melatonin and Cortisol. These alterations have been associated with delirium, fatigue, and higher mortality. In addition, sleep disturbances may remain after hospital discharge, and they have been associated with psychological comorbidities, which may contribute to the low quality of life observed in ICU survivors. Patient factors for sleep deprivation in ICU are the type/severity of underlying illness, the pathophysiology of the acute illness, pain, and stress/anxiety. Factors associated with the ICU, such as exposure to inadequate levels of light and noise, or inflexible schedules of daily care activities, have also been reported to have a major role in sleep disturbance. A limited number of studies have evaluated interventions targeting sleep optimization in the ICU, using strategies like eye masks and/or earplugs to isolate patients from their environment, the application of a dynamic light system that ensures light at night and higher levels of light at daytime to restore circadian rhythm, or auditory masking, to avoid intense cortical stimuli secondary to annoying noises. These strategies have been reported to have some positive impacts on sleep in ICU but this has only been assessed by qualitative instruments. In addition, they have been tested as isolated interventions, and not as part of a more comprehensive approach. The goal of this project is to determine the impact of a multifaceted intervention of environmental control in the ICU, based on dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities, on quantity and quality of sleep, assessed by polysomnography and other semi-quantitative methods, compared to standard care. In addition, the effect of both strategies on delirium, circadian rhythm biomarkers, and long-term neuropsychological outcomes will be compared. This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. After obtaining informed consent, patients will be randomized to receive a multifaceted intervention of environmental control or standard care. And this protocol will be applied from enrollment until ICU discharge, with a follow-up before hospital discharge and at 6 months.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | July 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient under invasive mechanical ventilation for at least 72 hours. - Patient without sedation or with superficial sedation level (SAS 3-4 by Sedation- Agitation Scale), during most of the daytime within the 24 previous hours Exclusion Criteria: - Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening. - Patients with primary neurological or neurosurgical disease. - Presence of mental or intellectual disability prior to hospitalization or communication/language barriers. - Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer). - Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization). - No fixed address for follow-up. - Patients with moderate to severe visual or hearing impairment. - Patients with known sleep disturbance before hospital admission. - Early limitation of therapeutic effort. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico UC CHRISTUS | Santiago | Región Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minutes in slow-wave sleep-N3 | Minutes in slow-wave sleep-N3 evaluated by Polysomnography. | Night 3 from enrollment. | |
Secondary | Minutes of rapid eye movement sleep | Minutes of rapid eye movement sleep evaluated by Polysomnography. | Night 3 from enrollment. | |
Secondary | Total sleep time | Assessed by actigraphy. It will report the total sleep duration in minutes within each 24-hour period. | From the first day after randomization, assessed up 1 week after ICU discharge. | |
Secondary | Change in Richards-Campbell Sleep Questionnaire (RCSQ) score | The Richards-Campbell Sleep Questionnaire (RCSQ) is a 5-item questionnaire used to evaluate perceived sleep depth, sleep latency, number of awakenings, efficiency, and sleep quality. Each RCSQ question is measured on a 0 (minimum) to 100 (maximum) visual-analog scale, with higher scores representing better sleep. | From the second day of enrollment until discharge from ICU, assessed up to day 28. | |
Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) score | The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measure seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality). | From the second day of enrollment until discharge from ICU, assessed up to day 28. | |
Secondary | Circadian rhythm | Oscillation of plasma concentration of melatonin and cortisol will be assessed. Five samples will be taken each day. | Melatonin and cortisol plasmatic levels will be assessed at the day 1 and 3 after randomization. | |
Secondary | Incidence of Delirium in ICU | The incidence of delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive. | From the first day of enrollment after randomization and until ICU discharge, assessed up to day 28. | |
Secondary | Duration of delirium (in days) | Evaluated by Confusion Assessment Method for the ICU (CAM-ICU). Duration of delirium will be defined as the total days of delirium during ICU stay. | From the first day of enrollment after randomization and until ICU discharge, assessed up to day 28. | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case. | 6 months post ICU discharge | |
Secondary | Global cognition as measured by Montreal Cognitive Assessment (MOCA) | Measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) | 6 months post ICU discharge. |
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