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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-01-26

Brief Summary

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Objectives and evaluation criteria:

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

Detailed Description

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Conditions

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D012893 Sleep Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Patients aged 60 and over hospitalized in a conventional medicine, psychiatry or medical and rehabilitation department of one of the GHT 49 healthcare establishments,
* Anticipated hospital stay \> 48 hours

Exclusion 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 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Angers_CHU

Angers, , France

Site Status

Etablissement de santé Baugeois-Vallée

Baugé-en-Anjou, , France

Site Status

CH de la corniche angevine

Chalonnes-sur-Loire, , France

Site Status

Cholet_Ch

Cholet, , France

Site Status

CH intercommunal Lys-Hyrôme

Cholet, , France

Site Status

Césame

Sainte-Gemmes-sur-Loire, , France

Site Status

CH Longué-Jumelles

Saumur, , France

Site Status

Saumur_Ch

Saumur, , France

Site Status

CH Doué-en-Anjou

Saumur, , France

Site Status

CH Layon-Aubance

Thouarcé, , France

Site Status

Countries

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France

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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