A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)
29. September 2022 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
- Verhalten: Sueña component 1: Sleep Hygiene Promotion
- Verhalten: Sueña component 2: Periodic Anxiety and Pain Screening
- Verhalten: Sueña component 3: Hypnotics and Caffeine Regulation
- Verhalten: Sueña component 4: Sleep Masks and Ear Plugs
- Sonstiges: Sueña component 5: Personalized Psychoeducation
- Gerät: Sueña component 6: Sleep Reports
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
120
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Constanza Caneo Robles, MD
- Telefonnummer: +56 9 4290 9250
- E-Mail: cmcaneo@uc.cl
Studieren Sie die Kontaktsicherung
- Name: Juan C Rodríguez, MD
- Telefonnummer: +56 9 4448 9732
- E-Mail: jcrtjcrt@gmail.com
Studienorte
-
-
Región Metropolitana
-
Santiago de Chile, Región Metropolitana, Chile, 7550000
- Rekrutierung
- Clínica San Carlos de Apoquindo UC
-
Unterermittler:
- Pedro Letelier Camus, MD
-
Unterermittler:
- Simón Medina, MD
-
Unterermittler:
- Matías Paredes Gálvez, BE
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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.
|
|
|
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.
|
|
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.
|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Total Sleep Time
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Mean Number and Total Duration of Nocturnal Awakenings
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Number and Total Duration of Naps During the Day
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Average Time of Falling Sleep and Awakening
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in time of day in 24-hour notation, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Sleep Architecture
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in minutes of total duration for each sleep phase (awake, light sleep, deep sleep and REM) and as a relative value of the total sleep time, using objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Sleep Onset Latency Mean Duration
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered sleep phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in REM Onset Latency Mean Duration
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered REM phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Wake After Sleep Onset Mean Duration
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in minutes of total time spent awake from the time of the first registered sleep phase to the time of the last registered awakening, using objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Sleep Efficiency
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in percentage of total time spent sleeping at night, calculated as total sleep time divided by total time spent in bed, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Heart Rate
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Number of Steps
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Level of Sound
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Change in Mean Level of Light
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in lux, using objective data registered by a lux meter placed in the participant's rooms.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Sleep Quality Perception
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Daytime Sleepiness
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured using the Epworth Sleepiness Scale (ESS), which considers 8 hypothetical situations and scores the likelihood of falling asleep from 0 to 3, and registers a total aggregated score (with a maximum total score of 24).
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Subjective Perception of Sleep-Disturbing Factors
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured using complementary questions regarding the presence/absence of factors (either environmental, symptomatological, or other) and their identification using predefined options: excessive light, excessive noise, interactions with health personnel, pain, anxiety, or others.
In case of selecting "others", a text field will be available for its description.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Pharmacological Indications and Need of SOS Medication
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Changes in Systolic and Diastolic Blood Pressure
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
|
|
Level of Pain
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
|
Measured with a Visual Analog Scale for Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
|
|
Level of Anxiety
Zeitfenster: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
|
Measured with a Visual Analog Scale for Anxiety (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.
|
From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
|
|
Change in Mean Length of Stay
Zeitfenster: From day 1 of hospitalization until discharge
|
Measured in days, using data from the participant's medical record.
|
From day 1 of hospitalization until discharge
|
|
Change in 30-day Readmission Rate
Zeitfenster: 30 days after the participant's discharge.
|
Measured as a proportion, using data from the participant's medical record and telephonic follow-up.
|
30 days after the participant's discharge.
|
|
Change in Participant Satisfaction Regarding Sleep During Hospitalization
Zeitfenster: 7 days after the participant's discharge.
|
Measurement of the subjective experience of the participant, using telephone surveys.
|
7 days after the participant's discharge.
|
|
Participant Satisfaction Regarding the Intervention
Zeitfenster: 7 days after the participant's discharge.
|
Measurement of the subjective experience of participants, using telephone surveys.
|
7 days after the participant's discharge.
|
|
Health Personnel Satisfaction and Agreeability Regarding the Intervention
Zeitfenster: Every 3 months through study completion, an average of 1.5 years
|
Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.
|
Every 3 months through study completion, an average of 1.5 years
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Studienleiter: Constanza Caneo Robles, MD, Pontifica Universidad Catolica de Chile
- Studienleiter: Juan C Rodríguez, MD, Pontifica Universidad Catolica de Chile
- Studienstuhl: María Rodríguez Fernández, PhD, Pontifica Universidad Catolica de Chile
- Studienstuhl: Marcela Babul, MD, Pontifica Universidad Catolica de Chile
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
22. Juni 2021
Primärer Abschluss (Voraussichtlich)
1. Dezember 2022
Studienabschluss (Voraussichtlich)
1. August 2023
Studienanmeldedaten
Zuerst eingereicht
22. Juli 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Juli 2021
Zuerst gepostet (Tatsächlich)
6. August 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. September 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. September 2022
Zuletzt verifiziert
1. September 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Erkrankungen des Nervensystems
- Schlaf-Wach-Störungen
- Dyssomnien
- Parasomnien
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Enzym-Inhibitoren
- Purinerge Antagonisten
- Purinerge Wirkstoffe
- Phosphodiesterase-Inhibitoren
- Purinerge P1-Rezeptorantagonisten
- Stimulanzien des zentralen Nervensystems
- Koffein
- Hypnotika und Beruhigungsmittel
Andere Studien-ID-Nummern
- Andere Zuschuss-/Finanzierungsnummer: Community Foundation of Greater Birmingham Women's Breast Health Fund
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
January 2024
IPD-Sharing-Zugriffskriterien
contact to responsable researcher C Caneo
Art der unterstützenden IPD-Freigabeinformationen
- Studienprotokoll
- Statistischer Analyseplan (SAP)
- Einwilligungserklärung (ICF)
- Klinischer Studienbericht (CSR)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .