Sleep DisordersNCT05996861
Protocol For Sleep for Critically Ill Patients
An observational study of Sleep Disorders, run by Hospital Moinhos de Vento at 2 sites in Brazil.
Trial summary
Sleep is essential for health and well-being. The quality of sleep impacts physical and cognitive aspects, including memory, immune system, and neuroendocrine function, with abnormalities associated with cardiovascular changes, neuropsychiatric disorders, and mortality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- ICU sleep protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Mar 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients admitted to the intensive care unit with a minimum stay of two nights
Who may be able to join
- Adult patients (18 years or older);
- Have spent at least two nights in the ICU;
- Neuropsychiatric conditions to respond to the sleep questionnaire Informed consent - authorization through the ICF (Informed Consent Form).
Who cannot join
- Neuropsychiatric conditions that prevent responding to the questionnaire, such as patients with dementia, severe sequelae of cerebrovascular disease, inability to understand and/or communicate, severe encephalopathy, deep sedation, acute brain dysfunction and/or delirium, visual and/or auditory acuity impairments that prevent responding to the questionnaire, active alcoholism, active illicit drug use, severe withdrawal symptoms;
- Patients with deep sedation that does not allow interaction with the evaluator;
- Moribund patients;
- Refusal to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Felippe Dexheimer contact
Brazil2 sites, 2 recruiting
- Recruiting
Unimed Vale dos Sinos Hospital
Novo Hamburgo, Rio Grande do Sul
- Recruiting
Moinhos de Vento Hospital
Porto Alegre, Rio Grande do Sul
About this study
Official title: Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients
Sleep is essential for health and well-being. The quality of sleep impacts physical and cognitive aspects, including memory, immune system, and neuroendocrine function, with abnormalities associated with cardiovascular changes, neuropsychiatric disorders, and mortality. Additionally, sleep disorders are related to an increased incidence of delirium in Intensive Care Units (ICUs). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. This study aims to demonstrate an improvement in sleep quality in critically ill patients through the reduction of the Richards-Campbell Sleep Questionnaire score and propose a package of measures to improve sleep practices in ICU-admitted patients.
Read the detailed description
Detailed description:
Critically ill patients are particularly vulnerable to sleep disorders. In the context of critical illness and ICU admission, there is an intersection of factors contributing to this situation: pre-existing health conditions, severe acute illness, sleep-altering treatments (sedatives, analgesics, mechanical ventilation), psychiatric disorders, and the physical environment. In addition to the impact during hospitalization, the literature points to a long-term reduction in quality of life due to sleep disturbance. Recent studies following up on patients after ICU discharge reveal high rates of sleep disorders up to 6 months after hospital discharge - related or unrelated to new psychiatric disorders and even cognitive changes. Furthermore, sleep disorders are associated with an increased incidence of delirium in ICUs, which refers to altered consciousness and cognition in patients admitted to the intensive care environment, which are associated with worsened patient outcomes such as increased hospital stay and consequently the risk of fatal complications. The prevalence of delirium is around 70%, with an incidence of 89%. Delirium assessment in ICUs is usually performed daily.
In order to improve the sleep quality of this population, there are modifiable factors, whether environmental (lighting, noise, general care), physiological (medications, ventilatory parameter adjustments), or psychological (anxiety, pain, absence of family members). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. These measures include dimming or reducing corridor lights at night, grouping (when possible) care activities at appropriate times, raising curtains, and encouraging mobilization during daytime shifts. For non-delirious patients, the use of earplugs and eye masks is also recommended.
Therefore, the investigators have developed this research project with the aim of evaluating the implementation of a multifaceted and multidisciplinary protocol to promote an improvement in sleep quality in critically ill patients.
The SPIRIT Protocol is a summary of recommendations for clinical trials, which was used as a support in this study. This is a multicenter clinical trial with a quasi-experimental design.
The first step consists of assessing the sleep quality in sequential patients admitted to the ICU and characterizing the disruptive elements.
After this period, the second step will involve sensitizing and training the multidisciplinary team about the importance of sleep for critically ill patients and providing training for the implementation of a multifaceted protocol of interventions to promote sleep quality improvement.
Once the multidisciplinary protocol is implemented, the sleep quality of the patients and the clinical impact of this protocol will be reevaluated.
- Conditions
- Sleep Disorders
- Being tested
- ICU sleep protocol
- Keywords
- Sleep, ICU, Delirium, Multidisciplinary Team, Sleep Protocol
- Medical subject headings
- Sleep Wake Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU sleep protocolBehavioural
Adjusting sound intensity, as well as reducing noise: efforts will be made to minimize staff conversation volume during the night.
Earplugs will be offered, along with the provision of eye masks for lucid patients, and thermal comfort adjustments will be made, such as providing blankets and/or adjusting room temperature.
Dimming of lights starting from 10 PM. Reduced circulation of external services between 11 PM and 6 AM, and rationalization of sample collections and/or patient transfers between beds during the 11 PM to 6 AM interval.
Optimization of analgesics for better pain control; optimization of medication use during wakefulness when clinically feasible; adjustment of intervals for capillary blood glucose measurement; maintaining and/or resuming the use of chronic sleep medications. If the patient has been unable to sleep, a hypnotic medication will be offered.
Other considerations include suggesting ventilatory support measures for selected patients.
| Study group | Role | What they receive |
|---|---|---|
| Pre-sleep protocol group | Patients with inclusion criteria assessed before the implementation of the sleep protocol. | |
| Post-sleep protocol group | Patients with inclusion criteria after the implementation of the sleep protocol. Receives: Behavioral: ICU sleep protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Richards-Campbell Sleep Quality Score
To demonstrate a better sleep quality in critical patients
Measured: before and one month after implementation of the sleep protocol
Secondary outcomes (6)
Change in the Sleep in the ICU Questionnaire
Characterization of the perception of factors influencing sleep in critically ill patients
Measured: before and one month after implementation of the sleep protocol
Change in the Confusion Assessment Method for the ICU
To evaluate the incidence of delirium and its duration according to sleep quality;
Measured: before and one month after implementation of the sleep protocol
Change in the Questionnaire on the patient's perception of sleep from the family member's point of view
To compare patient satisfaction at ICU discharge with family satisfaction
Measured: before and one month after implementation of the sleep protocol
Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocol
To assess the knowledge of the multidisciplinary team regarding sleep in critically ill patients before the implementation of the multidisciplinary protocol
Measured: before implementation of the sleep protocol
Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team
To assess the perception of the multidisciplinary team regarding the sleep quality of hospitalized patients after the implementation of the multidisciplinary protocol
Measured: one month after implementation of the sleep protocol
Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.
To evaluate the sleep quality of surviving patients of critical illnesses at ICU discharge
Measured: at three and six months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start20 Mar 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Drehmer, Hospital Moinhos de Vento
- Investigators
- Laura Drehmer, Principal investigator, Vale dos Sinos HospitalFelippe Dexheimer, Study director, Moinhos de Vento HospitalCassiano Teixeira, Study director, Moinhos de Vento Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996861
- Sponsor's protocol ID
- 842
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altman MT, Knauert MP, Pisani MA. Sleep Disturbance after Hospitalization and Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Sep;14(9):1457-1468. doi: 10.1513/AnnalsATS.201702-148SR.
PubMed 28644698Beltrami FG, John AB, de Macedo BR, Correa Junior V, Nguyen XL, Pichereau C, Maury E, Fleury B, Gus M, Fagondes SC. A multi-intervention protocol to improve sleep quality in a coronary care unit. Eur J Cardiovasc Nurs. 2022 Jun 30;21(5):464-472. doi: 10.1093/eurjcn/zvab099.
PubMed 34935040Ritmala-Castren M, Virtanen I, Vahlberg T, Leivo S, Kaukonen KM, Leino-Kilpi H. Evaluation of patients' sleep by nurses in an ICU. J Clin Nurs. 2016 Jun;25(11-12):1606-13. doi: 10.1111/jocn.13148. Epub 2016 Mar 18.
PubMed 26991592Ebben MR, Spielman AJ. Non-pharmacological treatments for insomnia. J Behav Med. 2009 Jun;32(3):244-54. doi: 10.1007/s10865-008-9198-8. Epub 2009 Jan 24.
PubMed 19169804Mori S, Takeda JR, Carrara FS, Cohrs CR, Zanei SS, Whitaker IY. Incidence and factors related to delirium in an intensive care unit. Rev Esc Enferm USP. 2016 Jul-Aug;50(4):587-593. doi: 10.1590/S0080-623420160000500007. English, Portuguese.
PubMed 27680043Richards KC, Wang YY, Jun J, Ye L. A Systematic Review of Sleep Measurement in Critically Ill Patients. Front Neurol. 2020 Nov 6;11:542529. doi: 10.3389/fneur.2020.542529. eCollection 2020.
PubMed 33240191Telias I, Wilcox ME. Sleep and Circadian Rhythm in Critical Illness. Crit Care. 2019 Mar 9;23(1):82. doi: 10.1186/s13054-019-2366-0.
PubMed 30850003Li SY, Wang TJ, Vivienne Wu SF, Liang SY, Tung HH. Efficacy of controlling night-time noise and activities to improve patients' sleep quality in a surgical intensive care unit. J Clin Nurs. 2011 Feb;20(3-4):396-407. doi: 10.1111/j.1365-2702.2010.03507.x.
PubMed 21219521
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05996861
- Acronym / sponsor ID
- 842
- Conditions
- Sleep Disorders
- Keywords
- Sleep, ICU, Delirium, Multidisciplinary Team, Sleep Protocol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is essential for health and well-being. The quality of sleep impacts physical and cognitive aspects, including memory, immune system, and neuroendocrine function, with abnormalities associated with cardiovascular changes, neuropsychiatric disorders, and mortality. Additionally, sleep disorders are related to an increased incidence of delirium in Intensive Care Units (ICUs). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. This study aims to demonstrate an improvement in sleep quality in critically ill patients through the reduction of the Richards-Campbell Sleep Questionnaire score and propose a package of measures to improve sleep practices in ICU-admitted patients.
Detailed description
Detailed description:
Critically ill patients are particularly vulnerable to sleep disorders. In the context of critical illness and ICU admission, there is an intersection of factors contributing to this situation: pre-existing health conditions, severe acute illness, sleep-altering treatments (sedatives, analgesics, mechanical ventilation), psychiatric disorders, and the physical environment. In addition to the impact during hospitalization, the literature points to a long-term reduction in quality of life due to sleep disturbance. Recent studies following up on patients after ICU discharge reveal high rates of sleep disorders up to 6 months after hospital discharge - related or unrelated to new psychiatric disorders and even cognitive changes. Furthermore, sleep disorders are associated with an increased incidence of delirium in ICUs, which refers to altered consciousness and cognition in patients admitted to the intensive care environment, which are associated with worsened patient outcomes such as increased hospital stay and consequently the risk of fatal complications. The prevalence of delirium is around 70%, with an incidence of 89%. Delirium assessment in ICUs is usually performed daily.
In order to improve the sleep quality of this population, there are modifiable factors, whether environmental (lighting, noise, general care), physiological (medications, ventilatory parameter adjustments), or psychological (anxiety, pain, absence of family members). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. These measures include dimming or reducing corridor lights at night, grouping (when possible) care activities at appropriate times, raising curtains, and encouraging mobilization during daytime shifts. For non-delirious patients, the use of earplugs and eye masks is also recommended.
Therefore, the investigators have developed this research project with the aim of evaluating the implementation of a multifaceted and multidisciplinary protocol to promote an improvement in sleep quality in critically ill patients.
The SPIRIT Protocol is a summary of recommendations for clinical trials, which was used as a support in this study. This is a multicenter clinical trial with a quasi-experimental design.
The first step consists of assessing the sleep quality in sequential patients admitted to the ICU and characterizing the disruptive elements.
After this period, the second step will involve sensitizing and training the multidisciplinary team about the importance of sleep for critically ill patients and providing training for the implementation of a multifaceted protocol of interventions to promote sleep quality improvement.
Once the multidisciplinary protocol is implemented, the sleep quality of the patients and the clinical impact of this protocol will be reevaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-sleep protocol group | – | –Patients with inclusion criteria assessed before the implementation of the sleep protocol. |
| Post-sleep protocol group | – | Behavioral: ICU sleep protocolPatients with inclusion criteria after the implementation of the sleep protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit with a minimum stay of two nights
Key inclusion criteria (3 listed)
- Adult patients (18 years or older);
- Have spent at least two nights in the ICU;
- Neuropsychiatric conditions to respond to the sleep questionnaire Informed consent - authorization through the ICF (Informed Consent Form).
Key exclusion criteria (4 listed)
- Neuropsychiatric conditions that prevent responding to the questionnaire, such as patients with dementia, severe sequelae of cerebrovascular disease, inability to understand and/or communicate, severe encephalopathy, deep sedation, acute brain dysfunction and/or delirium, visual and/or auditory acuity impairments that prevent responding to the questionnaire, active alcoholism, active illicit drug use, severe withdrawal symptoms;
- Patients with deep sedation that does not allow interaction with the evaluator;
- Moribund patients;
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU sleep protocolAdjusting sound intensity, as well as reducing noise: efforts will be made to minimize staff conversation volume during the night. Earplugs will be offered, along with the provision of eye masks for lucid patients, and thermal comfort adjustments will be made, such as providing blankets and/or adjusting room temperature. Dimming of lights starting from 10 PM. Reduced circulation of external services between 11 PM and 6 AM, and rationalization of sample collections and/or patient transfers between beds during the 11 PM to 6 AM interval. Optimization of analgesics for better pain control; optimization of medication use during wakefulness when clinically feasible; adjustment of intervals for capillary blood glucose measurement; maintaining and/or resuming the use of chronic sleep medications. If the patient has been unable to sleep, a hypnotic medication will be offered. Other considerations include suggesting ventilatory support measures for selected patients. | Behavioural | Post-sleep protocol group |
Primary outcome
Change in the Richards-Campbell Sleep Quality Score
Time frame: before and one month after implementation of the sleep protocol
To demonstrate a better sleep quality in critical patients
6 secondary outcomes
Change in the Sleep in the ICU Questionnaire
Time frame: before and one month after implementation of the sleep protocol
Change in the Confusion Assessment Method for the ICU
Time frame: before and one month after implementation of the sleep protocol
Change in the Questionnaire on the patient's perception of sleep from the family member's point of view
Time frame: before and one month after implementation of the sleep protocol
Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocol
Time frame: before implementation of the sleep protocol
Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team
Time frame: one month after implementation of the sleep protocol
Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.
Time frame: at three and six months after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 28644698Altman MT, Knauert MP, Pisani MA. Sleep Disturbance after Hospitalization and Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Sep;14(9):1457-1468. doi: 10.1513/AnnalsATS.201702-148SR.
- Background: PubMed 34935040Beltrami FG, John AB, de Macedo BR, Correa Junior V, Nguyen XL, Pichereau C, Maury E, Fleury B, Gus M, Fagondes SC. A multi-intervention protocol to improve sleep quality in a coronary care unit. Eur J Cardiovasc Nurs. 2022 Jun 30;21(5):464-472. doi: 10.1093/eurjcn/zvab099.
- Background: PubMed 26991592Ritmala-Castren M, Virtanen I, Vahlberg T, Leivo S, Kaukonen KM, Leino-Kilpi H. Evaluation of patients' sleep by nurses in an ICU. J Clin Nurs. 2016 Jun;25(11-12):1606-13. doi: 10.1111/jocn.13148. Epub 2016 Mar 18.
- Background: PubMed 19169804Ebben MR, Spielman AJ. Non-pharmacological treatments for insomnia. J Behav Med. 2009 Jun;32(3):244-54. doi: 10.1007/s10865-008-9198-8. Epub 2009 Jan 24.
- Background: PubMed 27680043Mori S, Takeda JR, Carrara FS, Cohrs CR, Zanei SS, Whitaker IY. Incidence and factors related to delirium in an intensive care unit. Rev Esc Enferm USP. 2016 Jul-Aug;50(4):587-593. doi: 10.1590/S0080-623420160000500007. English, Portuguese.
- Background: PubMed 33240191Richards KC, Wang YY, Jun J, Ye L. A Systematic Review of Sleep Measurement in Critically Ill Patients. Front Neurol. 2020 Nov 6;11:542529. doi: 10.3389/fneur.2020.542529. eCollection 2020.
- Background: PubMed 30850003Telias I, Wilcox ME. Sleep and Circadian Rhythm in Critical Illness. Crit Care. 2019 Mar 9;23(1):82. doi: 10.1186/s13054-019-2366-0.
- Results publication: PubMed 21219521Li SY, Wang TJ, Vivienne Wu SF, Liang SY, Tung HH. Efficacy of controlling night-time noise and activities to improve patients' sleep quality in a surgical intensive care unit. J Clin Nurs. 2011 Feb;20(3-4):396-407. doi: 10.1111/j.1365-2702.2010.03507.x.
- SPIRIT 2013 ChecklistLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felippe Dexheimer contact
Laura Drehmer principal investigator
Vale dos Sinos Hospital
Felippe Dexheimer study director
Moinhos de Vento Hospital
Cassiano Teixeira study director
Moinhos de Vento Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, run by Hospital Moinhos de Vento at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Drehmer (5551999886722, laura.drehmer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Richards-Campbell Sleep Quality Score (time frame: before and one month after implementation of the sleep protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996861, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.