Dyssomnias
Conditions
Keywords
Sleep, Psychiatric Intensive Care Unit, Multicomponent Intervention, Wearable Activity Tracker, Behavioral Intervention, Psychoeducation, Environmental Interventions
Brief 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 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.
Interventions
BEHAVIORALSueña component 1: Sleep Hygiene Promotion
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.
BEHAVIORALSueña component 2: Periodic Anxiety and Pain Screening
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.
BEHAVIORALSueña component 3: Hypnotics and Caffeine Regulation
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.
BEHAVIORALSueña component 4: Sleep Masks and Ear Plugs
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.
OTHERSueña component 5: Personalized Psychoeducation
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.
DEVICESueña component 6: Sleep Reports
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
Sponsors
UC CHRISTUS
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Two investigators will work on-site collecting data for each of the variables, uploading them to a secure database (REDCap) as anonymous data. Afterwards, data and outcomes will be analyzed by a blinded investigator.
Intervention model description
Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized in the last 72 hours. * Capacity to consent * Approval by treating physician
Exclusion criteria
* Active psychosis * Active eating disorder * Delirium * Major cognitive disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sleep Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Number and Total Duration of Naps During the Day | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Average Time of Falling Sleep and Awakening | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Sleep Architecture | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Sleep Onset Latency Mean Duration | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in REM Onset Latency Mean Duration | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Wake After Sleep Onset Mean Duration | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Sleep Efficiency | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Change in Mean Heart Rate | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed. |
| Change in Mean Number of Steps | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices. |
| Change in Mean Level of Sound | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms. |
| Change in Mean Level of Light | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured in lux, using objective data registered by a lux meter placed in the participant's rooms. |
| Change in Mean Number and Total Duration of Nocturnal Awakenings | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Changes in Daytime Sleepiness | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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). |
| Changes in Subjective Perception of Sleep-Disturbing Factors | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 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. |
| Changes in Pharmacological Indications and Need of SOS Medication | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart. |
| Changes in Systolic and Diastolic Blood Pressure | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart. |
| Level of Pain | 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. | 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. |
| Level of Anxiety | 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. | 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. |
| Change in Mean Length of Stay | From day 1 of hospitalization until discharge | Measured in days, using data from the participant's medical record. |
| Change in 30-day Readmission Rate | 30 days after the participant's discharge. | Measured as a proportion, using data from the participant's medical record and telephonic follow-up. |
| Change in Participant Satisfaction Regarding Sleep During Hospitalization | 7 days after the participant's discharge. | Measurement of the subjective experience of the participant, using telephone surveys. |
| Participant Satisfaction Regarding the Intervention | 7 days after the participant's discharge. | Measurement of the subjective experience of participants, using telephone surveys. |
| Health Personnel Satisfaction and Agreeability Regarding the Intervention | Every 3 months through study completion, an average of 1.5 years | Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys. |
| Changes in Sleep Quality Perception | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains. |
Countries
Chile
Contacts
Primary ContactConstanza Caneo Robles, MD
Backup ContactJuan C Rodríguez, MD
Outcome results
None listed