Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3 (TOPASE)

August 21, 2025 updated by: University Hospital, Angers

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France, 49933
    - Angers_CHU
  - Baugé-en-Anjou, France, 49250
    - Etablissement de santé Baugeois-Vallée
  - Chalonnes-sur-Loire, France, 49290
    - CH de la corniche angevine
  - Cholet, France, 49300
    - Cholet_Ch
  - Cholet, France, 49310
    - CH intercommunal Lys-Hyrôme
  - Sainte-Gemmes-sur-Loire, France, 49130
    - Césame
  - Saumur, France, 49400
    - CH Longué-Jumelles
  - Saumur, France, 49400
    - Saumur_Ch
  - Saumur, France, 49700
    - CH Doué-en-Anjou
  - Thouarcé, France, 49540
    - CH Layon-Aubance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale. Time Frame: 3 days	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. 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. NB: - Spiegel score ranks from 0 to 30 (Questionnaire)	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants numbers repartitions within departments categories following their spiegel score Time Frame: 3 days	There is three categories: conventional medicine, psychiatry or medical care and rehabilitation. Spiegel score ranks from 0 to 30 (Questionnaire)	3 days
Distributions of the number of participants within hospital facility types following their Spiegel score Time Frame: 3 days	Four hospital categories: university hospitals, city hospitals, specialized hospitals and community hospitasl. Spiegel score ranks from 0 to 30	3 days
Distribution of the number of participants in the different room types according to their Spiegel score Time Frame: 3 days	Three different room types: Single or double without roomate and full double room Spiegel score ranks from 0 to 30	3 days
Distributions of the number of participants by age group following Spiegel score Time Frame: 3 days	Three age categories: 60-74 years, 75-89 years, 90 years and above Spiegel score ranks from 0 to 30	3 days
Distribution of number of participants by gender and Spiegel score Time Frame: 3 days	Gender Spiegel score ranks from 0 to 30	3 days
Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire). Time Frame: 3 days	Was your sleep disturbed last night? 0 No 1 Yes If yes : Anxiety Need to go to the toilet Noise Change in rhythm of life (mealtimes, bedtimes, toilet times, etc.) Medical devices (e.g. infusion, urinary catheter, dressing, etc.) Pain Light My illness (clinical signs) Lack of physical activity during the day Smell Visits from carers Taking medication to sleep / absence / modification of usual treatment Quality of bedding Feeling hungry or thirsty Room temperature Room neighbor Other : ________________________________________________	3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Actual)

January 26, 2025

Study Completion (Actual)

January 26, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

49RC24_0305
2024-A01996-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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