Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
NCT ID: NCT06659575
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2025-01-20
2025-01-26
Brief Summary
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The main objective of this study is to evaluate changes in sleep quality in patients aged 60 and over since their admission to a medical, psychiatric or medical and rehabilitation ward in one of the GHT 49 healthcare establishments.
The primary endpoint will be the difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
Research plan and procedure:
Patients participating in the study will be asked to complete a questionnaire including the Spiegel scale at two points during their hospitalization:
* Day 0: questionnaire n°1 to assess sleep quality on the night prior to hospitalization, including the Spiegel scale.
* Day 2 (morning of the third day of hospitalization): during the morning, depending on the organization of the ward, questionnaire n°2 to assess sleep quality during the previous night, including the Spiegel scale.
Number of research participants:
As the study is essentially descriptive, aimed at taking stock of the situation, the calculation of the number of patients to be included was not based on a hypothesis test.
Pragmatically, the investigator plan to include the maximum number of patients meeting the criteria during the targeted week.
Given the number of beds in the GHT 49 establishments in the departments concerned, and the average number of new admissions, the investigator estimate that 200 patients could be included.
Research duration:
Inclusion period: 5 days, Monday to Friday Participation period: 3 days (from day 0 to day 2) Study duration: 7 days
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients aged 60 and over hospitalized, expected length of stay > 48 hours
Inclusion criteria
* Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
* expected length of stay \> 48 hours.
Non-inclusion criteria
* Patient hospitalized for more than 24 hours,
* Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
* No command of French,
* Patient hospitalized for sleep pathology (evaluation or treatment),
* Patient hospitalized in an intensive psychiatric care room,
* Patients hospitalized under duress,
* Patient opposition,
* Patient under guardianship or curatorship.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Anticipated hospital stay \> 48 hours
Exclusion Criteria
* Inability to answer a questionnaire (assessment by the investigator or the medical team in charge of the patient (dementia, etc.),
* No mastery of French
* Patient hospitalized for sleep pathology (evaluation or treatment),
* Patient hospitalized in an intensive psychiatric care room,
* Patients hospitalized under duress,
* Patient opposition,
* Patient under guardianship or curatorship.
60 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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Angers_CHU
Angers, , France
Etablissement de santé Baugeois-Vallée
Baugé-en-Anjou, , France
CH de la corniche angevine
Chalonnes-sur-Loire, , France
Cholet_Ch
Cholet, , France
CH intercommunal Lys-Hyrôme
Cholet, , France
Césame
Sainte-Gemmes-sur-Loire, , France
CH Longué-Jumelles
Saumur, , France
Saumur_Ch
Saumur, , France
CH Doué-en-Anjou
Saumur, , France
CH Layon-Aubance
Thouarcé, , France
Countries
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Other Identifiers
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2024-A01996-41
Identifier Type: OTHER
Identifier Source: secondary_id
49RC24_0305
Identifier Type: -
Identifier Source: org_study_id
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