A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)
29 september 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
- Gedragsmatig: Sueña component 1: Sleep Hygiene Promotion
- Gedragsmatig: Sueña component 2: Periodic Anxiety and Pain Screening
- Gedragsmatig: Sueña component 3: Hypnotics and Caffeine Regulation
- Gedragsmatig: Sueña component 4: Sleep Masks and Ear Plugs
- Ander: Sueña component 5: Personalized Psychoeducation
- Apparaat: Sueña component 6: Sleep Reports
Studietype
Ingrijpend
Inschrijving (Verwacht)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Constanza Caneo Robles, MD
- Telefoonnummer: +56 9 4290 9250
- E-mail: cmcaneo@uc.cl
Studie Contact Back-up
- Naam: Juan C Rodríguez, MD
- Telefoonnummer: +56 9 4448 9732
- E-mail: jcrtjcrt@gmail.com
Studie Locaties
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Región Metropolitana
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Santiago de Chile, Región Metropolitana, Chili, 7550000
- Werving
- Clínica San Carlos de Apoquindo UC
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Onderonderzoeker:
- Pedro Letelier Camus, MD
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Onderonderzoeker:
- Simón Medina, MD
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Onderonderzoeker:
- Matías Paredes Gálvez, BE
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: 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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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Total Sleep Time
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Mean Number and Total Duration of Nocturnal Awakenings
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie directeur: Constanza Caneo Robles, MD, Pontifica Universidad Catolica De Chile
- Studie directeur: Juan C Rodríguez, MD, Pontifica Universidad Catolica De Chile
- Studie stoel: María Rodríguez Fernández, PhD, Pontifica Universidad Catolica De Chile
- Studie stoel: Marcela Babul, MD, Pontifica Universidad Catolica De Chile
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 juni 2021
Primaire voltooiing (Verwacht)
1 december 2022
Studie voltooiing (Verwacht)
1 augustus 2023
Studieregistratiedata
Eerst ingediend
22 juli 2021
Eerst ingediend dat voldeed aan de QC-criteria
31 juli 2021
Eerst geplaatst (Werkelijk)
6 augustus 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 september 2022
Laatste update ingediend die voldeed aan QC-criteria
29 september 2022
Laatst geverifieerd
1 september 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Ziekten van het zenuwstelsel
- Slaap-waakstoornissen
- Dyssomnieën
- Parasomnieën
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Enzymremmers
- Purinerge antagonisten
- Purinerge middelen
- Fosfodiësteraseremmers
- Purinerge P1-receptorantagonisten
- Stimulerende middelen voor het centrale zenuwstelsel
- Cafeïne
- Hypnotica en sedativa
Andere studie-ID-nummers
- Andere identificatie: No secondary ID
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
January 2024
IPD-toegangscriteria voor delen
contact to responsable researcher C Caneo
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
- Formulier voor geïnformeerde toestemming (ICF)
- Klinisch onderzoeksrapport (CSR)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .