Clinical trial NCT06659575: Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
Official title: Prevalence of Sleep Disturbances in Elderly People Hospitalized in Medicine, Psychiatry and Rehabilitation Departments: TOPASE Prospective Study, RIPH 3
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: D012893
Sleep Disorder
Keywords: Sleep Wake Disorders
Sleep
elderly
hospitalized
recovery process
rehospitalizations
overmedication
iatrogenics
daytime sleepiness
fatigue
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: The difference between the usual sleep quality score and the sleep quality score during hospitalization, according to the Spiegel scale.
timeFrame: 3 days
Secondary outcomes:
measure: Participants numbers repartitions within departments categories following their spiegel score
timeFrame: 3 days
measure: Distributions of the number of participants within hospital facility types following their Spiegel score
timeFrame: 3 days
measure: Distribution of the number of participants in the different room types according to their Spiegel score
timeFrame: 3 days
measure: Distributions of the number of participants by age group following Spiegel score
timeFrame: 3 days
measure: Distribution of number of participants by gender and Spiegel score
timeFrame: 3 days
measure: Distribution of the number of patients within a list of different reported causes of sleep disorders (Questionnaire).
timeFrame: 3 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers_CHU
city: Beaufort-en-Anjou
country: France
facility: Etablissement de santé Baugeois-Vallée
city: Chalonnes-sur-Loire
country: France
facility: CH de la corniche angevine
city: Cholet
country: France
facility: Cholet_Ch
city: Doué-en-Anjou
country: France
facility: CH Doué-en-Anjou
city: Lys-Haut-Layon
country: France
facility: CH intercommunal Lys-Hyrôme
city: Sainte Gemmes-sur-Loire
country: France
facility: Césame
city: Saumur
country: France
facility: CH Longué-Jumelles
city: Saumur
country: France
facility: Saumur_Ch
city: Terranjou
country: France
facility: CH Layon-Aubance
Study officials:
References: