A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)
29 de septiembre de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
- Conductual: Sueña component 1: Sleep Hygiene Promotion
- Conductual: Sueña component 2: Periodic Anxiety and Pain Screening
- Conductual: Sueña component 3: Hypnotics and Caffeine Regulation
- Conductual: Sueña component 4: Sleep Masks and Ear Plugs
- Otro: Sueña component 5: Personalized Psychoeducation
- Dispositivo: Sueña component 6: Sleep Reports
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Constanza Caneo Robles, MD
- Número de teléfono: +56 9 4290 9250
- Correo electrónico: cmcaneo@uc.cl
Copia de seguridad de contactos de estudio
- Nombre: Juan C Rodríguez, MD
- Número de teléfono: +56 9 4448 9732
- Correo electrónico: jcrtjcrt@gmail.com
Ubicaciones de estudio
-
-
Región Metropolitana
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Santiago de Chile, Región Metropolitana, Chile, 7550000
- Reclutamiento
- Clínica San Carlos de Apoquindo UC
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Sub-Investigador:
- Pedro Letelier Camus, MD
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Sub-Investigador:
- Simón Medina, MD
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Sub-Investigador:
- Matías Paredes Gálvez, BE
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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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Experimental: 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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Experimental: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Total Sleep Time
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Mean Number and Total Duration of Nocturnal Awakenings
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Constanza Caneo Robles, MD, Pontifica Universidad Catolica de Chile
- Director de estudio: Juan C Rodríguez, MD, Pontifica Universidad Catolica de Chile
- Silla de estudio: María Rodríguez Fernández, PhD, Pontifica Universidad Catolica de Chile
- Silla de estudio: Marcela Babul, MD, Pontifica Universidad Catolica de Chile
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de junio de 2021
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de agosto de 2023
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2021
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2021
Publicado por primera vez (Actual)
6 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
29 de septiembre de 2022
Última verificación
1 de septiembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades del Sistema Nervioso
- Trastornos del sueño y la vigilia
- Disomnias
- Parasomnias
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Inhibidores de enzimas
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Inhibidores de la fosfodiesterasa
- Antagonistas del receptor P1 purinérgico
- Estimulantes del Sistema Nervioso Central
- Cafeína
- Hipnóticos y sedantes
Otros números de identificación del estudio
- Otro número de subvención/financiamiento: Community Foundation of Greater Birmingham Women's Breast Health Fund
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan 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.
Marco de tiempo para compartir IPD
January 2024
Criterios de acceso compartido de IPD
contact to responsable researcher C Caneo
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .