DyssomniasSUEÑA-SMNCT04995263
A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit
A study testing Sueña component 1: Sleep Hygiene Promotion, Sueña component 2: Periodic Anxiety and Pain Screening and Sueña component 3: Hypnotics and Caffeine Regulation in people with Dyssomnias, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyssomnias
- What is being tested?
- Sueña component 1: Sleep Hygiene Promotion, Sueña component 2: Periodic Anxiety and Pain Screening and Sueña component 3: Hypnotics and Caffeine Regulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChile
- Study dates
- 22 Jun 2021to 1 Aug 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in the last 72 hours.
- Capacity to consent
- Approval by treating physician
Who cannot join
- Active psychosis
- Active eating disorder
- Delirium
- Major cognitive disorder
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clínica San Carlos de Apoquindo UC
Santiago, Santiago Metropolitan, 7550000
Pedro Letelier Camus, MD
Simón Medina, MD
About this study
Official title: A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial
Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.
- Conditions
- Dyssomnias
- Being tested
- Sueña component 1: Sleep Hygiene Promotion, Sueña component 2: Periodic Anxiety and Pain Screening, Sueña component 3: Hypnotics and Caffeine Regulation, Sueña component 4: Sleep Masks and Ear Plugs, Sueña component 5: Personalized Psychoeducation
- Keywords
- Sleep, Psychiatric Intensive Care Unit, Multicomponent Intervention, Wearable Activity Tracker, Behavioral Intervention, Psychoeducation, Environmental Interventions
- Medical subject headings
- Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sueña component 1: Sleep Hygiene PromotionBehavioural
The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.
Sueña component 2: Periodic Anxiety and Pain ScreeningBehavioural
Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.
Sueña component 3: Hypnotics and Caffeine RegulationBehavioural
The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.
Sueña component 4: Sleep Masks and Ear PlugsBehavioural
Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.
Sueña component 5: Personalized PsychoeducationOther
Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.
Sueña component 6: Sleep ReportsDevice
Objective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention, control group | No intervention | A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention. Estimated duration 3 months, n = 30. |
| Post-intervention, SUEÑA half bundle, active group 1 | Experimental | Post-intervention, environmental and behavioral modifications in patient care interventions.
Implementation of components 1 through 4 of SUEÑA intervention in the entire PICU unit. All participants will be exposed to the intervention. Estimated duration: 3 months, n = 30. Receives: Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs |
| Post-intervention, randomization for SUEÑA half bundle plus, active group 2 | Experimental | Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment.
Participants will be randomized to receive SUEÑA components 1 through 5 Estimated duration: 6 months, n = 30 Receives: Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs; Other: Sueña component 5: Personalized Psychoeducation |
| Post-intervention, randomization for SUEÑA full bundle, active group 3 | Experimental | Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment and personalized psychoeducation.
. Participants will be randomized to receive SUEÑA components 1 through 6. Estimated duration: 6 months, n = 30 Receives: Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs; Other: Sueña component 5: Personalized Psychoeducation; Device: Sueña component 6: Sleep Reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Sleep Time
Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary outcomes (24)
Change in Mean Number and Total Duration of Nocturnal Awakenings
Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Number and Total Duration of Naps During the Day
Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Average Time of Falling Sleep and Awakening
Measured in time of day in 24-hour notation, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Architecture
Measured in minutes of total duration for each sleep phase (awake, light sleep, deep sleep and REM) and as a relative value of the total sleep time, using objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Onset Latency Mean Duration
Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered sleep phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in REM Onset Latency Mean Duration
Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered REM phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Wake After Sleep Onset Mean Duration
Measured in minutes of total time spent awake from the time of the first registered sleep phase to the time of the last registered awakening, using objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Efficiency
Measured in percentage of total time spent sleeping at night, calculated as total sleep time divided by total time spent in bed, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Heart Rate
Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Number of Steps
Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Level of Sound
Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Level of Light
Measured in lux, using objective data registered by a lux meter placed in the participant's rooms.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Sleep Quality Perception
Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Daytime Sleepiness
Measured using the Epworth Sleepiness Scale (ESS), which considers 8 hypothetical situations and scores the likelihood of falling asleep from 0 to 3, and registers a total aggregated score (with a maximum total score of 24).
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Subjective Perception of Sleep-Disturbing Factors
Measured using complementary questions regarding the presence/absence of factors (either environmental, symptomatological, or other) and their identification using predefined options: excessive light, excessive noise, interactions with health personnel, pain, anxiety, or others. In case of selecting "others", a text field will be available for its description.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Pharmacological Indications and Need of SOS Medication
Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Systolic and Diastolic Blood Pressure
Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Level of Pain
Measured with a Visual Analog Scale for Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Level of Anxiety
Measured with a Visual Analog Scale for Anxiety (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.
Measured: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Change in Mean Length of Stay
Measured in days, using data from the participant's medical record.
Measured: From day 1 of hospitalization until discharge
Change in 30-day Readmission Rate
Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
Measured: 30 days after the participant's discharge.
Change in Participant Satisfaction Regarding Sleep During Hospitalization
Measurement of the subjective experience of the participant, using telephone surveys.
Measured: 7 days after the participant's discharge.
Participant Satisfaction Regarding the Intervention
Measurement of the subjective experience of participants, using telephone surveys.
Measured: 7 days after the participant's discharge.
Health Personnel Satisfaction and Agreeability Regarding the Intervention
Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.
Measured: Every 3 months through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start22 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for DyssomniasStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- UC CHRISTUS
- Responsible party
- Principal investigator, Constanza Caneo, Pontificia Universidad Catolica de Chile
- Investigators
- Constanza Caneo Robles, MD, Study director, Pontifica Universidad Católica de ChileJuan C Rodríguez, MD, Study director, Pontifica Universidad Católica de ChileMaría Rodríguez Fernández, PhD, Study chair, Pontifica Universidad Católica de ChileMarcela Babul, MD, Study chair, Pontifica Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995263
- Sponsor's protocol ID
- 0
- Acronym
- SUEÑA-SM
- Status last verified
- Sep 2022
- First submitted
- 22 Jul 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.
Publications
Bano M, Chiaromanni F, Corrias M, Turco M, De Rui M, Amodio P, Merkel C, Gatta A, Mazzotta G, Costa R, Montagnese S. The influence of environmental factors on sleep quality in hospitalized medical patients. Front Neurol. 2014 Dec 11;5:267. doi: 10.3389/fneur.2014.00267. eCollection 2014.
PubMed 25566173Bernhofer EI, Higgins PA, Daly BJ, Burant CJ, Hornick TR. Hospital lighting and its association with sleep, mood and pain in medical inpatients. J Adv Nurs. 2014 May;70(5):1164-73. doi: 10.1111/jan.12282. Epub 2013 Oct 27.
PubMed 24164506Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. doi: 10.1111/j.1365-2044.2004.03664.x.
PubMed 15023109Denkinger MD, Lindemann U, Nicolai S, Igl W, Jamour M, Nikolaus T. Assessing Physical Activity in Inpatient Rehabilitation: validity, practicality, and sensitivity to change in the physical activity in inpatient rehabilitation assessment. Arch Phys Med Rehabil. 2011 Dec;92(12):2012-7. doi: 10.1016/j.apmr.2011.06.032.
PubMed 22133250Horne S, Hay K, Watson S, Anderson KN. An evaluation of sleep disturbance on in-patient psychiatric units in the UK. BJPsych Bull. 2018 Oct;42(5):193-197. doi: 10.1192/bjb.2018.42.
PubMed 30229719Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.
PubMed 26439374Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108.
PubMed 27473952Lawrence G, Muza R. Assessing the sleeping habits of patients in a sleep disorder centre: a review of sleep diary accuracy. J Thorac Dis. 2018 Jan;10(Suppl 1):S177-S183. doi: 10.21037/jtd.2017.12.127.
PubMed 29445542Milani RV, Bober RM, Lavie CJ, Wilt JK, Milani AR, White CJ. Reducing Hospital Toxicity: Impact on Patient Outcomes. Am J Med. 2018 Aug;131(8):961-966. doi: 10.1016/j.amjmed.2018.04.013. Epub 2018 May 3.
PubMed 29729240Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. doi: 10.7748/ns2013.08.27.49.35.e7649.
PubMed 23924135Rodriguez JC, Dzierzewski JM, Alessi CA. Sleep problems in the elderly. Med Clin North Am. 2015 Mar;99(2):431-9. doi: 10.1016/j.mcna.2014.11.013. Epub 2014 Dec 30.
PubMed 25700593Sandoval-Rincon M, Alcala-Lozano R, Herrera-Jimenez I, Jimenez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish.
PubMed 23999632Stewart NH, Arora VM. Sleep in Hospitalized Older Adults. Sleep Med Clin. 2018 Mar;13(1):127-135. doi: 10.1016/j.jsmc.2017.09.012. Epub 2017 Nov 10.
PubMed 29412979Tamrat R, Huynh-Le MP, Goyal M. Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014 May;29(5):788-95. doi: 10.1007/s11606-013-2640-9. Epub 2013 Oct 10.
PubMed 24113807Tembo AC, Parker V. Factors that impact on sleep in intensive care patients. Intensive Crit Care Nurs. 2009 Dec;25(6):314-22. doi: 10.1016/j.iccn.2009.07.002. Epub 2009 Oct 31.
PubMed 19880319
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04995263
- Acronym / sponsor ID
- SUEÑA-SM / 0
- Conditions
- Dyssomnias
- Keywords
- Sleep, Psychiatric Intensive Care Unit, Multicomponent Intervention, Wearable Activity Tracker, Behavioral Intervention, Psychoeducation, Environmental Interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- UC CHRISTUS
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 6 Aug 2021 (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.
Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention, control group | No intervention | –A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention. Estimated duration 3 months, n = 30. |
| Post-intervention, SUEÑA half bundle, active group 1 | Experimental | Behavioral: Sueña component 1: Sleep Hygiene Promotion, Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening, Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation, Behavioral: Sueña component 4: Sleep Masks and Ear PlugsPost-intervention, environmental and behavioral modifications in patient care interventions. Implementation of components 1 through 4 of SUEÑA intervention in the entire PICU unit. All participants will be exposed to the intervention. Estimated duration: 3 months, n = 30. |
| Post-intervention, randomization for SUEÑA half bundle plus, active group 2 | Experimental | Behavioral: Sueña component 1: Sleep Hygiene Promotion, Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening, Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation, Behavioral: Sueña component 4: Sleep Masks and Ear Plugs, Other: Sueña component 5: Personalized PsychoeducationRandomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment. Participants will be randomized to receive SUEÑA components 1 through 5 Estimated duration: 6 months, n = 30 |
| Post-intervention, randomization for SUEÑA full bundle, active group 3 | Experimental | Behavioral: Sueña component 1: Sleep Hygiene Promotion, Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening, Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation, Behavioral: Sueña component 4: Sleep Masks and Ear Plugs, Other: Sueña component 5: Personalized Psychoeducation, Device: Sueña component 6: Sleep ReportsRandomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment and personalized psychoeducation. . Participants will be randomized to receive SUEÑA components 1 through 6. Estimated duration: 6 months, n = 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized in the last 72 hours.
- Capacity to consent
- Approval by treating physician
Key exclusion criteria (4 listed)
- Active psychosis
- Active eating disorder
- Delirium
- Major cognitive disorder
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 |
|---|---|---|
| Sueña component 1: Sleep Hygiene PromotionThe nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician. | Behavioural | Post-intervention, SUEÑA half bundle, active group 1, Post-intervention, randomization for SUEÑA full bundle, active group 3, Post-intervention, randomization for SUEÑA half bundle plus, active group 2 |
| Sueña component 2: Periodic Anxiety and Pain ScreeningEvery night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement. | Behavioural | Post-intervention, SUEÑA half bundle, active group 1, Post-intervention, randomization for SUEÑA full bundle, active group 3, Post-intervention, randomization for SUEÑA half bundle plus, active group 2 |
| Sueña component 3: Hypnotics and Caffeine RegulationThe use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM. | Behavioural | Post-intervention, SUEÑA half bundle, active group 1, Post-intervention, randomization for SUEÑA full bundle, active group 3, Post-intervention, randomization for SUEÑA half bundle plus, active group 2 |
| Sueña component 4: Sleep Masks and Ear PlugsSleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM. | Behavioural | Post-intervention, SUEÑA half bundle, active group 1, Post-intervention, randomization for SUEÑA full bundle, active group 3, Post-intervention, randomization for SUEÑA half bundle plus, active group 2 |
| Sueña component 5: Personalized PsychoeducationTwo individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families. | Other | Post-intervention, randomization for SUEÑA full bundle, active group 3, Post-intervention, randomization for SUEÑA half bundle plus, active group 2 |
| Sueña component 6: Sleep ReportsObjective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management | Device | Post-intervention, randomization for SUEÑA full bundle, active group 3 |
Primary outcome
Change in Total Sleep Time
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables.
24 secondary outcomes
Change in Mean Number and Total Duration of Nocturnal Awakenings
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Number and Total Duration of Naps During the Day
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Average Time of Falling Sleep and Awakening
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Architecture
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Onset Latency Mean Duration
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in REM Onset Latency Mean Duration
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Wake After Sleep Onset Mean Duration
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Sleep Efficiency
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Heart Rate
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Number of Steps
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Level of Sound
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Change in Mean Level of Light
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Sleep Quality Perception
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Daytime Sleepiness
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Subjective Perception of Sleep-Disturbing Factors
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Pharmacological Indications and Need of SOS Medication
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Changes in Systolic and Diastolic Blood Pressure
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Level of Pain
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Level of Anxiety
Time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Change in Mean Length of Stay
Time frame: From day 1 of hospitalization until discharge
Change in 30-day Readmission Rate
Time frame: 30 days after the participant's discharge.
Change in Participant Satisfaction Regarding Sleep During Hospitalization
Time frame: 7 days after the participant's discharge.
Participant Satisfaction Regarding the Intervention
Time frame: 7 days after the participant's discharge.
Health Personnel Satisfaction and Agreeability Regarding the Intervention
Time frame: Every 3 months through study completion, an average of 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 25566173Bano M, Chiaromanni F, Corrias M, Turco M, De Rui M, Amodio P, Merkel C, Gatta A, Mazzotta G, Costa R, Montagnese S. The influence of environmental factors on sleep quality in hospitalized medical patients. Front Neurol. 2014 Dec 11;5:267. doi: 10.3389/fneur.2014.00267. eCollection 2014.
- Background: PubMed 24164506Bernhofer EI, Higgins PA, Daly BJ, Burant CJ, Hornick TR. Hospital lighting and its association with sleep, mood and pain in medical inpatients. J Adv Nurs. 2014 May;70(5):1164-73. doi: 10.1111/jan.12282. Epub 2013 Oct 27.
- Background: PubMed 15023109Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. doi: 10.1111/j.1365-2044.2004.03664.x.
- Background: PubMed 22133250Denkinger MD, Lindemann U, Nicolai S, Igl W, Jamour M, Nikolaus T. Assessing Physical Activity in Inpatient Rehabilitation: validity, practicality, and sensitivity to change in the physical activity in inpatient rehabilitation assessment. Arch Phys Med Rehabil. 2011 Dec;92(12):2012-7. doi: 10.1016/j.apmr.2011.06.032.
- Background: PubMed 30229719Horne S, Hay K, Watson S, Anderson KN. An evaluation of sleep disturbance on in-patient psychiatric units in the UK. BJPsych Bull. 2018 Oct;42(5):193-197. doi: 10.1192/bjb.2018.42.
- Background: PubMed 26439374Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.
- Background: PubMed 27473952Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108.
- Background: PubMed 29445542Lawrence G, Muza R. Assessing the sleeping habits of patients in a sleep disorder centre: a review of sleep diary accuracy. J Thorac Dis. 2018 Jan;10(Suppl 1):S177-S183. doi: 10.21037/jtd.2017.12.127.
- Background: PubMed 29729240Milani RV, Bober RM, Lavie CJ, Wilt JK, Milani AR, White CJ. Reducing Hospital Toxicity: Impact on Patient Outcomes. Am J Med. 2018 Aug;131(8):961-966. doi: 10.1016/j.amjmed.2018.04.013. Epub 2018 May 3.
- Background: PubMed 23924135Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. doi: 10.7748/ns2013.08.27.49.35.e7649.
- Background: PubMed 25700593Rodriguez JC, Dzierzewski JM, Alessi CA. Sleep problems in the elderly. Med Clin North Am. 2015 Mar;99(2):431-9. doi: 10.1016/j.mcna.2014.11.013. Epub 2014 Dec 30.
- Background: PubMed 23999632Sandoval-Rincon M, Alcala-Lozano R, Herrera-Jimenez I, Jimenez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish.
- Individual participant dataSharing planned: Yes. We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.
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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.
Constanza Caneo Robles, MD study director
Pontifica Universidad Católica de Chile
Juan C Rodríguez, MD study director
Pontifica Universidad Católica de Chile
María Rodríguez Fernández, PhD study chair
Pontifica Universidad Católica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sueña component 1: Sleep Hygiene Promotion, Sueña component 2: Periodic Anxiety and Pain Screening and Sueña component 3: Hypnotics and Caffeine Regulation in people with Dyssomnias, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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 Constanza Caneo Robles, MD (+56 9 4290 9250, cmcaneo@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Sleep Time (time frame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.). 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 NCT04995263, which also lists 18 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 30 Sep 2022.