A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)
29 września 2022 zaktualizowane przez: Constanza Caneo, Pontificia Universidad Catolica de Chile
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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
- Behawioralne: Sueña component 1: Sleep Hygiene Promotion
- Behawioralne: Sueña component 2: Periodic Anxiety and Pain Screening
- Behawioralne: Sueña component 3: Hypnotics and Caffeine Regulation
- Behawioralne: Sueña component 4: Sleep Masks and Ear Plugs
- Inny: Sueña component 5: Personalized Psychoeducation
- Urządzenie: Sueña component 6: Sleep Reports
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
120
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Constanza Caneo Robles, MD
- Numer telefonu: +56 9 4290 9250
- E-mail: cmcaneo@uc.cl
Kopia zapasowa kontaktu do badania
- Nazwa: Juan C Rodríguez, MD
- Numer telefonu: +56 9 4448 9732
- E-mail: jcrtjcrt@gmail.com
Lokalizacje studiów
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Región Metropolitana
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Santiago de Chile, Región Metropolitana, Chile, 7550000
- Rekrutacyjny
- Clínica San Carlos de Apoquindo UC
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Pod-śledczy:
- Pedro Letelier Camus, MD
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Pod-śledczy:
- Simón Medina, MD
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Pod-śledczy:
- Matías Paredes Gálvez, BE
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Pre-intervention, control group
A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention.
Estimated duration 3 months, n = 30.
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Eksperymentalny: Post-intervention, SUEÑA half bundle, active group 1
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. |
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.
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.
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.
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.
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Eksperymentalny: Post-intervention, randomization for SUEÑA half bundle plus, active group 2
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 |
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.
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.
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.
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.
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.
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Eksperymentalny: Post-intervention, randomization for SUEÑA full bundle, active group 3
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 |
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.
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.
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.
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.
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.
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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Total Sleep Time
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Mean Number and Total Duration of Nocturnal Awakenings
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Mean Number and Total Duration of Naps During the Day
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Average Time of Falling Sleep and Awakening
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Sleep Architecture
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Sleep Onset Latency Mean Duration
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in REM Onset Latency Mean Duration
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Wake After Sleep Onset Mean Duration
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Sleep Efficiency
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Mean Heart Rate
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Mean Number of Steps
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Mean Level of Sound
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Change in Mean Level of Light
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured in lux, using objective data registered by a lux meter placed in the participant's rooms.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Changes in Sleep Quality Perception
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Changes in Daytime Sleepiness
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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).
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Changes in Subjective Perception of Sleep-Disturbing Factors
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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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.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Changes in Pharmacological Indications and Need of SOS Medication
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Changes in Systolic and Diastolic Blood Pressure
Ramy czasowe: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.
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From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
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Level of Pain
Ramy czasowe: 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.
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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.
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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.
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Level of Anxiety
Ramy czasowe: 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.
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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.
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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.
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Change in Mean Length of Stay
Ramy czasowe: From day 1 of hospitalization until discharge
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Measured in days, using data from the participant's medical record.
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From day 1 of hospitalization until discharge
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Change in 30-day Readmission Rate
Ramy czasowe: 30 days after the participant's discharge.
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Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
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30 days after the participant's discharge.
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Change in Participant Satisfaction Regarding Sleep During Hospitalization
Ramy czasowe: 7 days after the participant's discharge.
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Measurement of the subjective experience of the participant, using telephone surveys.
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7 days after the participant's discharge.
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Participant Satisfaction Regarding the Intervention
Ramy czasowe: 7 days after the participant's discharge.
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Measurement of the subjective experience of participants, using telephone surveys.
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7 days after the participant's discharge.
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Health Personnel Satisfaction and Agreeability Regarding the Intervention
Ramy czasowe: Every 3 months through study completion, an average of 1.5 years
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Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.
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Every 3 months through study completion, an average of 1.5 years
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Dyrektor Studium: Constanza Caneo Robles, MD, Pontifica Universidad Catolica de Chile
- Dyrektor Studium: Juan C Rodríguez, MD, Pontifica Universidad Catolica de Chile
- Krzesło do nauki: María Rodríguez Fernández, PhD, Pontifica Universidad Catolica de Chile
- Krzesło do nauki: Marcela Babul, MD, Pontifica Universidad Catolica de Chile
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Kanji 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.
- Tembo 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.
- Hu 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.
- 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.
- Bernhofer 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.
- Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. Review.
- Denkinger 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.
- Horne 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.
- Lawrence 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.
- Milani 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.
- Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. Review.
- Rodriguez 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. Review.
- Sandoval-Rincón M, Alcalá-Lozano R, Herrera-Jiménez I, Jiménez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish.
- Stewart 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. Review.
- Tamrat 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.
- Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. Review.
- Wesselius HM, van den Ende ES, Alsma J, Ter Maaten JC, Schuit SCE, Stassen PM, de Vries OJ, Kaasjager KHAH, Haak HR, van Doormaal FF, Hoogerwerf JJ, Terwee CB, van de Ven PM, Bosch FH, van Someren EJW, Nanayakkara PWB; "Onderzoeks Consortium Acute Geneeskunde" Acute Medicine Research Consortium. Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients. JAMA Intern Med. 2018 Sep 1;178(9):1201-1208. doi: 10.1001/jamainternmed.2018.2669.
- Novak C, Packer E, Paterson A, Roshi A, Locke R, Keown P, Watson S, Anderson KN. Feasibility and utility of enhanced sleep management on in-patient psychiatry wards. BJPsych Bull. 2020 Dec;44(6):255-260. doi: 10.1192/bjb.2020.30.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
22 czerwca 2021
Zakończenie podstawowe (Oczekiwany)
1 grudnia 2022
Ukończenie studiów (Oczekiwany)
1 sierpnia 2023
Daty rejestracji na studia
Pierwszy przesłany
22 lipca 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 lipca 2021
Pierwszy wysłany (Rzeczywisty)
6 sierpnia 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 września 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 września 2022
Ostatnia weryfikacja
1 września 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Choroby Układu Nerwowego
- Zaburzenia snu i czuwania
- Dyssomnie
- Parasomnie
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Depresanty ośrodkowego układu nerwowego
- Inhibitory enzymów
- Antagonistów purynergicznych
- Środki purynergiczne
- Inhibitory fosfodiesterazy
- Antagoniści receptora purynergicznego P1
- Stymulatory ośrodkowego układu nerwowego
- Kofeina
- Środki nasenne i uspokajające
Inne numery identyfikacyjne badania
- Inny numer grantu/finansowania: Community Foundation of Greater Birmingham Women's Breast Health Fund
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAk
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
January 2024
Kryteria dostępu do udostępniania IPD
contact to responsable researcher C Caneo
Typ informacji pomocniczych dotyczących udostępniania IPD
- Protokół badania
- Plan analizy statystycznej (SAP)
- Formularz świadomej zgody (ICF)
- Raport z badania klinicznego (CSR)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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