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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06659575
Acronym
TOPASE
Enrollment
104
Registered
2024-10-26
Start date
2025-01-20
Completion date
2025-01-26
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D012893, Sleep Disorder

Keywords

Sleep Wake Disorders, Sleep, elderly, hospitalized, recovery process, rehospitalizations, overmedication, iatrogenics, daytime sleepiness, fatigue

Brief summary

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

Interventions

None listed

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.3 daysThe 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)

Secondary

MeasureTime frameDescription
Distributions of the number of participants within hospital facility types following their Spiegel score3 days* Four hospital categories: university hospitals, city hospitals, specialized hospitals and community hospitasl. * Spiegel score ranks from 0 to 30
Distribution of the number of participants in the different room types according to their Spiegel score3 days* Three different room types: Single or double without roomate and full double room * Spiegel score ranks from 0 to 30
Participants numbers repartitions within departments categories following their spiegel score3 days* There is three categories: conventional medicine, psychiatry or medical care and rehabilitation. * Spiegel score ranks from 0 to 30 (Questionnaire)
Distribution of number of participants by gender and Spiegel score3 days* Gender * Spiegel score ranks from 0 to 30
Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).3 daysWas 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 : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Distributions of the number of participants by age group following Spiegel score3 days* Three age categories: 60-74 years, 75-89 years, 90 years and above * Spiegel score ranks from 0 to 30

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026