NCT04113876

Brief Summary

This study evaluates the quality of sleep of patients admitted to medical and intensive care units. All of them will have a clock placed to measure their circadian activity. Also, data will be recorded through questionnaires about the unit, patient habits and medical problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

September 6, 2019

Last Update Submit

February 28, 2023

Conditions

Chronobiology Disorders

Keywords

sleep qualitycircadian rhythmnursing activities

Outcome Measures

Primary Outcomes (1)

  • Circadian Health

    Using the KRONOHEALTH® recording device, we will measure the following indicators: * Total Sleep Time * Sleep Fragmentations * Sleep depth * Chronobiological health index

    96 hours

Secondary Outcomes (2)

  • Subjective Sleep Quality

    1 day (one time evaluation)

  • Degree of sleep interference during hospitalization

    1 day (one time evaluation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Users who are part of the study must be adults admitted to intensive care units (ICUs), Medical Units (UMs) and Surgical units (UQs), of the 13 participating hospitals: Andalusia (H. Juan Ramón Jiménez, Huelva), Catalonia (H. Mataró and H. Arnau Villanova, Lleida), Cantabria (HU Marqués Valdecilla), Castilla y León (H. del Bierzo, Ponferrada), Castila-La Mancha (HGU Ciudad Real), C. Madrid (HU 12 de Octubre ), C. Valenciana (HGU Valencia and HGU Alicante), Murcia Region (C H Cartagena, HCU V Arrixaca) and Basque Country (H. Basurto, Bilbao and H. Galdakao-Usansolo, Vizcaya).

You may qualify if:

  • subjects over 18 years of age, minimum duration of the hospitalization process of 96h, conscious and oriented with constancy in their clinical history (HC) and who give their consent.

You may not qualify if:

  • personas con discapacidad visual y/o auditiva documentada en su HC, en el caso de los pacientes de Unidades de Cuidados Intensivos (UCIs) se excluirán a aquellos que obtengan una puntuación inferior a 8 en la escala Glasgow. Pacientes con cualquier tipo de aislamiento y aquellos incluidos en el plan de Cuidados Paliativos.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teresa Moreno Casbas

Madrid, 28029, Spain

Location

Related Publications (27)

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    RESULT

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    RESULT

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    PMID: 23515802RESULT

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    PMID: 26148316RESULT

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    PMID: 26468189RESULT

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    PMID: 10704520RESULT

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    PMID: 19454302RESULT

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    PMID: 11604479RESULT

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    PMID: 17369106RESULT

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    PMID: 22553268RESULT

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    PMID: 19084897RESULT

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    PMID: 19497681RESULT

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    PMID: 11163282RESULT

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    PMID: 26483931RESULT

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    PMID: 25852963RESULT

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    PMID: 12749557RESULT

  • Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.

    PMID: 17520797RESULT

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    PMID: 2748771RESULT

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    PMID: 1798888RESULT

MeSH Terms

Conditions

Chronobiology DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Clinical Research

Study Record Dates

First Submitted

September 6, 2019

First Posted

October 3, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)